Thursday, September 15, 2005
Gone for a few days and then to BUKO
I am gone for a few days, but as usual I take some PDS literature with me! :-) Next week I will attend the German association's annual conference called BUKO: check here. I am invited to speak and participate in a discussion round on therapies. I am representing Luxembourg, and also England partially.
Tuesday, September 13, 2005
How good is Lidcombe?
I admit that I am not an expert on the details of the Lidcombe therapy. So please correct me when I go off stage. But here are some (possibly controversial) thoughts:
1) I am still not 100% convinced that research has conclusively shown that the Lidcombe therapy gives lasting and clearly-above the natural recovery rate fluency to dysfluent kids.
2) The people who do Lidcombe therapy have no precise understanding why it should work, apart from some general intuition that targeted practise and "pressure" will change the children's behaviour.
3) Any intervention (whether Lidcombe or something else) might have an effect.
4) Politically speaking, Lidcombe is wonderful whether it is effective or not. And I tell you why. Parents dont want people like me telling them: "Well, 80% recover anyway. There two approaches. One say X and the other says Y. Lidcombe might be good but who knows" They want CERTAINTY: "Yes, we can solve your child's problem. And we tell you how to help them." And even if this certainty is completely misguided. The absurd fact is that 80% of the parents will be very satisfied! Their thinking goes: "our child did Lidcombe - problem solved - Lidcombe is an effective therapy".
5) Intuitively, Lidcombe could well at least partially be a consequence of the male big belly phenomenon. You tell them: "You have a big belly". And they strengthen their stomach muscles and the big belly is suddenly gone. No big belly anymore! Hey. But then after a while, the big belly comes back. And so to Liddcombe. The big belly is the dysfluency. The Lidcombe therapy is the "pressure" or "re-enforcement" of a different than naturally developed behaviour. And it could well be that after this period the child goes naturally back to its natural behaviour. But I agree that at this young age the effect for permanent change is greater. But it could well be that some aspects of the child's brain, like speech and language circuits, are hard to change after the age 3 to 4, whereas others like movements, habits, pyschological or social certainly are. So it is very important to follow up the kids over several years after they have left Lidcombe. And any outcome study should study possible relapse too.
6) What part of Lidcombe does the treatment effect?
FINALLY, 7) Research on Lidcombe therapy has clearly shown that the days of Johnson & co are numbered. Where are the kids that should recover less often if you make them aware of their stuttering? Very clearly, giving Licombe to kids does not make them stutter more...that is for sure.
In this light, Lidcombe deserves credit! And the supporter of Johnson & co's approaches to stuttering must seriously review their own thinking, not just for kids but also for adults. NO, stuttering is not caused by self-identity issues (they view themselves as stutterers, if they did not have that view, they would not stutter). Stuttering causes people to develop an too unrealistically negative view of themselves as speakers that their speech impediment forces on them.
1) I am still not 100% convinced that research has conclusively shown that the Lidcombe therapy gives lasting and clearly-above the natural recovery rate fluency to dysfluent kids.
2) The people who do Lidcombe therapy have no precise understanding why it should work, apart from some general intuition that targeted practise and "pressure" will change the children's behaviour.
3) Any intervention (whether Lidcombe or something else) might have an effect.
4) Politically speaking, Lidcombe is wonderful whether it is effective or not. And I tell you why. Parents dont want people like me telling them: "Well, 80% recover anyway. There two approaches. One say X and the other says Y. Lidcombe might be good but who knows" They want CERTAINTY: "Yes, we can solve your child's problem. And we tell you how to help them." And even if this certainty is completely misguided. The absurd fact is that 80% of the parents will be very satisfied! Their thinking goes: "our child did Lidcombe - problem solved - Lidcombe is an effective therapy".
5) Intuitively, Lidcombe could well at least partially be a consequence of the male big belly phenomenon. You tell them: "You have a big belly". And they strengthen their stomach muscles and the big belly is suddenly gone. No big belly anymore! Hey. But then after a while, the big belly comes back. And so to Liddcombe. The big belly is the dysfluency. The Lidcombe therapy is the "pressure" or "re-enforcement" of a different than naturally developed behaviour. And it could well be that after this period the child goes naturally back to its natural behaviour. But I agree that at this young age the effect for permanent change is greater. But it could well be that some aspects of the child's brain, like speech and language circuits, are hard to change after the age 3 to 4, whereas others like movements, habits, pyschological or social certainly are. So it is very important to follow up the kids over several years after they have left Lidcombe. And any outcome study should study possible relapse too.
6) What part of Lidcombe does the treatment effect?
FINALLY, 7) Research on Lidcombe therapy has clearly shown that the days of Johnson & co are numbered. Where are the kids that should recover less often if you make them aware of their stuttering? Very clearly, giving Licombe to kids does not make them stutter more...that is for sure.
In this light, Lidcombe deserves credit! And the supporter of Johnson & co's approaches to stuttering must seriously review their own thinking, not just for kids but also for adults. NO, stuttering is not caused by self-identity issues (they view themselves as stutterers, if they did not have that view, they would not stutter). Stuttering causes people to develop an too unrealistically negative view of themselves as speakers that their speech impediment forces on them.
Saturday, September 10, 2005
Against everything we believed in
Lidcombe has first been heavily critised by many, but nowadays the therapy is The Answer to childhood dysfluency for many. I tend to believe that both are wrong (but Lidcombe is less wrong that the others) and that I have no answer either!!! :-)
It is intriguing that the Lidcombe approach is a 100% contradiction to the old ways of doing things: let me call them psycho theories (for simplicity - and I dont deny psycho influence in PDS). Johnson, Sheehan, and Bloodstein have said in the past that
You can imagine that the "establishment" (I love conspiracy theories... :-) was not very pleased to hear about the Lidcombe therapy that instructs parents to do what supposedly causes adult stuttering! I do admit that the parent psycho theory is quite elegant and makes a lot of sense and explains why some children do not recover from dysfluencies, namely their parents, so it is a shame that the theory is dead wrong! For several reasons:
1) Lidcombe therapy does at the very least not produce more stuttering teenagers than natural recovery. If the parent psycho theory were true, many more kids should keep on stuttering!!! So even if Lidcombe does not have a treatment impact, at the very least it convincingly refutes the parent psycho theory. How can anyone anymore take the warnings seriously that parents should whenever possible avoid telling the child about their disfluency or else their kids face life-long stuttering?
2) Recent research has shown that girls and those without family history seem to recover in greater numbers. So the parent psycho theory need to explain why girls and those without family history are LESS receptive to interactions with their parents?
3) There are many kids who recover who had much greater pressure from their parents.
4) It is a myth that parents have very much impact of their kids.
In my next post, some comments on Lidcombe.
It is intriguing that the Lidcombe approach is a 100% contradiction to the old ways of doing things: let me call them psycho theories (for simplicity - and I dont deny psycho influence in PDS). Johnson, Sheehan, and Bloodstein have said in the past that
Stuttering is a disorder of the social presentation of the self. Basically, stuttering is not a speech disorder but a conflict resolving around self and role, an identity problem. (Sheehan)Extrapolating, one conclusion is that parents' intervention and attitude towards a child's dysfluencies causes stuttering. Many children go through a normal period of dysfluecnies. Parents make them aware of these dysfluencies. The children (and parents) get more anxious and therefore stutter even more and keep on stuttering. Thus, many therapists and doctors in the past urged parents to avoid whenever possible to make their children aware of their dysfluencies.
You can imagine that the "establishment" (I love conspiracy theories... :-) was not very pleased to hear about the Lidcombe therapy that instructs parents to do what supposedly causes adult stuttering! I do admit that the parent psycho theory is quite elegant and makes a lot of sense and explains why some children do not recover from dysfluencies, namely their parents, so it is a shame that the theory is dead wrong! For several reasons:
1) Lidcombe therapy does at the very least not produce more stuttering teenagers than natural recovery. If the parent psycho theory were true, many more kids should keep on stuttering!!! So even if Lidcombe does not have a treatment impact, at the very least it convincingly refutes the parent psycho theory. How can anyone anymore take the warnings seriously that parents should whenever possible avoid telling the child about their disfluency or else their kids face life-long stuttering?
2) Recent research has shown that girls and those without family history seem to recover in greater numbers. So the parent psycho theory need to explain why girls and those without family history are LESS receptive to interactions with their parents?
3) There are many kids who recover who had much greater pressure from their parents.
4) It is a myth that parents have very much impact of their kids.
In my next post, some comments on Lidcombe.
Wednesday, September 07, 2005
How good are your stats?
I am currently looking carefully at the statistics of the Lidcombe study. I have already done some work months ago. The big big problem with evaluating children therapies is that you never quite know whether they recover naturally or due to your intervention. [Another issue is whether the recovery due to your intervention happens faster than the natural recovery.]
For example, let's say the natural recovery rate is 70%. Then roughly 700 kids out of 1000 kids should recover. Let give treatment to 20 kids, and 16 kids recover. This makes a recovery rate of 80%, which is 10% higher than the 70%. But it could well be a statistical fluctuation as you have picked 20 kids randomly for the population of all kids that are dysfluent. So by chance you might end up with 16 kids that will eventually naturally recover. The trick is either large sample size or large treatment effect. Thus, the larger your sample of kids, the less likely the natural recovery rate in the sample deviates from the 70%. And the larger your treatment the clearer you deviate from the 70%. I derived a mathematical formula to compute the chance that a result is a fluke. And the higher the recovery rate of the sample you have treated and the larger your sample size, the lower the likelihood of a fluke. Do you follow me??? :-) You can also do it with a Monte Carlo simulation, but this gets a bit technical!
Here is my rapid response. I found already a small spelling mistake. I hate when that happens. I read it several times and then I sent it off and then I spotted the spelling mistake... I am curious what others have to say about my response. I guess 90% have no clue what I am talking about. So I hope for the 10% to either agree or prove me wrong.
For example, let's say the natural recovery rate is 70%. Then roughly 700 kids out of 1000 kids should recover. Let give treatment to 20 kids, and 16 kids recover. This makes a recovery rate of 80%, which is 10% higher than the 70%. But it could well be a statistical fluctuation as you have picked 20 kids randomly for the population of all kids that are dysfluent. So by chance you might end up with 16 kids that will eventually naturally recover. The trick is either large sample size or large treatment effect. Thus, the larger your sample of kids, the less likely the natural recovery rate in the sample deviates from the 70%. And the larger your treatment the clearer you deviate from the 70%. I derived a mathematical formula to compute the chance that a result is a fluke. And the higher the recovery rate of the sample you have treated and the larger your sample size, the lower the likelihood of a fluke. Do you follow me??? :-) You can also do it with a Monte Carlo simulation, but this gets a bit technical!
Here is my rapid response. I found already a small spelling mistake. I hate when that happens. I read it several times and then I sent it off and then I spotted the spelling mistake... I am curious what others have to say about my response. I guess 90% have no clue what I am talking about. So I hope for the 10% to either agree or prove me wrong.
Tuesday, September 06, 2005
What is Lidcombe?
The Lidcombe therapy was developed by Prof. Mark Onslow and others (sorry if I dont have names). It is foremost a behavioural therapy, and tries to change the speech behaviour of the children by enlisting the parents to point out fluent speech and dysfluent speech.
Here is a description of Lidcombe, which I have shortened a bit:
Here is a description of Lidcombe, which I have shortened a bit:
The program is administered by a parent (or carer) in the child's everyday environment. Parents learn how to do the treatment during weekly visits to the speech pathologist. At these visits, the speech pathologist trains the parent by demonstrating various features of the treatment, observing the parent do the treatment, and giving the parent feedback about how they are going with the treatment. This parent training is essential, because it is the speech pathologist's responsibility to ensure that the treatment is done appropriately and is a positive experience for the child and the family.
The treatment is direct. This means that it involves the parent commenting directly about the child's speech. This parental feedback is overwhelmingly positive, because the parent comments primarily when the child speaks fluently and only occasionally when the child stutters. The parent does not comment on the child's speech all the time, but chooses specific times during the day in which to give the child feedback.
As well as learning how to give feedback effectively, the parent also learns to measure the child's stuttering by scoring it....
The Lidcombe Program is conducted in two stages. In Stage 1, the parent conducts the treatment each day and the parent and child attend the speech clinic once a week. This continues until stuttering either disappears or reaches a very low level. Stage 2 of the program commences at this point. The aim of Stage 2 is to maintain the absence, or low level, of stuttering for at least one year. The frequency of parental feedback during Stage 2 is reduced, as is the frequency of clinic visits, providing that stuttering remains at the low level at entry to Stage 2. This maintenance part of the program is essential because it is well known that stuttering may reappear after the conclusion of an apparently successful treatment. (taken from the Australian Stuttering Research Centre site)
Saturday, September 03, 2005
Lidcombe randomized trial
I have decided to become a bit more of a scientist again, which means that I will pick out a few interesting articles and comment on them.
I am currently reading a therapy outcome study on the Lidcombe treatment for children. The article by Jones, Onslow, Packmann et al. is published in the British Medical Journal under the title "Randomised controlled trial of the Lidcombe programme of early stuttering intervention". Look at the abstract. You can also download the pdf file.
As I said many times before, outcome studies are very tricky to do, and on treating children is even more tricky due to the natural recovery rate. Thus, if a child becomes fluent after treatment, was it a natural recovery or the result of the treatment? The only way to do this is to look at a larger sample of children. I will talk about it more in my next post.
I am currently reading a therapy outcome study on the Lidcombe treatment for children. The article by Jones, Onslow, Packmann et al. is published in the British Medical Journal under the title "Randomised controlled trial of the Lidcombe programme of early stuttering intervention". Look at the abstract. You can also download the pdf file.
As I said many times before, outcome studies are very tricky to do, and on treating children is even more tricky due to the natural recovery rate. Thus, if a child becomes fluent after treatment, was it a natural recovery or the result of the treatment? The only way to do this is to look at a larger sample of children. I will talk about it more in my next post.
Friday, September 02, 2005
Visitor from Pakistan
I just noticed that I had a visitor from Pakistan. If you read this, please post a comment and tell us what is going on stuttering-wise in your country!
Tuesday, August 30, 2005
PDS in old age
Do older people show less symptoms of PDS or are there fewer to have PDS? I gave a talk at the Oxford Dysfluency Conference, where I showed that the attendance of therapy is declining with age. I argued that the effect is not due to the fact that fewer older people stutter, but due to other reasons: see my post. But a few people said that there is a decline in age. But I havent found any very convincing articles yet. I just looked at the internet and couldnt find anything in 5 minutes. (So it cannot exist. :-)
I also have conceptual problems to believe it as it doesnt fit in well with my understanding of PDS. If it's really a defect somewhere, then how can old age make it better? Or if there are compensationary systems, then shouldnt young people be more likely to stutter less? The only reason I can come up with is that the neurotransmitter balance is changing, which then affects the severity of PDS symptoms. So if there is clear research showing that older people stutter less, then this seems to point to a dependence on the neurotransmitter systems. Well, I guess you can also argue that people calm down and have less energy to stutter!
I also have conceptual problems to believe it as it doesnt fit in well with my understanding of PDS. If it's really a defect somewhere, then how can old age make it better? Or if there are compensationary systems, then shouldnt young people be more likely to stutter less? The only reason I can come up with is that the neurotransmitter balance is changing, which then affects the severity of PDS symptoms. So if there is clear research showing that older people stutter less, then this seems to point to a dependence on the neurotransmitter systems. Well, I guess you can also argue that people calm down and have less energy to stutter!
Sunday, August 28, 2005
Why are you so scared?
Over the last weeks, I have been reading a German discussion forum. I was amazed to discover how many were very scared of speaking situations, and tried everything possible to avoid them. One person is getting married this weekend, and the whole forum including him and his wife spent so much time trying to come up with tricks so that he doesn't have to speak.
I know what it feels like to be in such a state. I was the same when I was young(er). But strangely enough, after the age of 20 I am not scared at all at any situation, even though I do stutter in most of the situations. I am still wondering why? Is it because I attended therapy and met other people with PDS? Or is it just an hormonal change and my true personality shines through? :-)
Anyway, reading the posts has made aware again that the handicap arising from PDS is NOT JUST dysfluency, but for many (especially those that never had contact with other people with PDS) can impact life very dramatically. But their current (and my past) behaviour is completely irrational. You have the choice: being scared like hell or worrying for a week before the speaking situation and then stuttering, or not worrying and stuttering. Isn't the choice obvious? I guess the solution is "to do what you fear", and the fear will dissolve if the fear is irrational. In fact, I believe that many people with PDS can reduce their fear substantially by attending group therapy, and speak or "stutter" in a safe environment. Making you mentally fluent is easier than physically fluent.
To finish off, let me tell you what might have made me fear less: A dream! One day I was dreaming about being chased by a few people. I was always running away and I always ended up on the top of a cliff line. Obviously, there was no escape route, and the closer they came the more scared I got. But one day I realized that I was dreaming, and being a physicist I realized: "Hey, inside dreams the laws of physics don't apply!!!!!" So I decided to fly away! This happened in several dreams. So I could always fly away, but after a while I got bored by running away. So then one night I realized again that I was dreaming and I told myself: "I am so sick of running away. Let them kill me. Physics doesn't apply. But would be cool to see what would happen if you get killed in your own dream." So instead of flying away, I turned around and stood there waiting for them to come closer. And then they got scared and run away. And I started chasing them!! From then onwards, I hardly had nightmares anymore... :-)
I know what it feels like to be in such a state. I was the same when I was young(er). But strangely enough, after the age of 20 I am not scared at all at any situation, even though I do stutter in most of the situations. I am still wondering why? Is it because I attended therapy and met other people with PDS? Or is it just an hormonal change and my true personality shines through? :-)
Anyway, reading the posts has made aware again that the handicap arising from PDS is NOT JUST dysfluency, but for many (especially those that never had contact with other people with PDS) can impact life very dramatically. But their current (and my past) behaviour is completely irrational. You have the choice: being scared like hell or worrying for a week before the speaking situation and then stuttering, or not worrying and stuttering. Isn't the choice obvious? I guess the solution is "to do what you fear", and the fear will dissolve if the fear is irrational. In fact, I believe that many people with PDS can reduce their fear substantially by attending group therapy, and speak or "stutter" in a safe environment. Making you mentally fluent is easier than physically fluent.
To finish off, let me tell you what might have made me fear less: A dream! One day I was dreaming about being chased by a few people. I was always running away and I always ended up on the top of a cliff line. Obviously, there was no escape route, and the closer they came the more scared I got. But one day I realized that I was dreaming, and being a physicist I realized: "Hey, inside dreams the laws of physics don't apply!!!!!" So I decided to fly away! This happened in several dreams. So I could always fly away, but after a while I got bored by running away. So then one night I realized again that I was dreaming and I told myself: "I am so sick of running away. Let them kill me. Physics doesn't apply. But would be cool to see what would happen if you get killed in your own dream." So instead of flying away, I turned around and stood there waiting for them to come closer. And then they got scared and run away. And I started chasing them!! From then onwards, I hardly had nightmares anymore... :-)
Friday, August 26, 2005
Visitor from Kuwait!
I just noticed that my blog had a visitor from Kuwait. There are very very few people from Asia. I would be interested to know what is happening regarding PDS in Arabic countries. Maybe there is a stuttering oil sheik who can sponsor my blog! :-) If you are from Asia, please post a comment or send me an email. I would love to hear from you.
Thursday, August 25, 2005
Between speech and language?
What can happen, will happen somewhere sometime! A quote from my old physics professor at university. You can modify the statement to: What works, will break down somewhere sometime! This realisation leads to be a beautiful analogy between body disorders and body functions. For example in the brain, every brain function must give rise to at least one brain disorder. So the spectrum of brain disorders is a reflection of the functions of the brain. So how about PDS?
The intriguing thing is that PDS does not seem to be a fundamental malfunction of language nor of speech. Virtually all people with PDS have the ability to speak completely fluently at times and in certain situations. If you mix their fluent speech samples with samples of normal speakers, I bet with you that a listener will not be able to distinguish between the two groups. So we do have the ability to speak, and we are not like some people who cannot pronounce certain sounds or control their speech rate. Concerning language, no-one to my knowledge has ever shown that people with PDS have clear language deficits (like in dyslexia), but possibly very subtle ones.
But to what brain function does PDS link if not language or speech? My answer is that PDS is not a total breakdown of a brain function, but only an unstable underperforming brain function. Moreover, PDS is probably not about a specific brain function, but about the malfunctioning interplay between different brain functions, probably the integration between different information from different brain regions. In a sense, it is in between speech and language.
The intriguing thing is that PDS does not seem to be a fundamental malfunction of language nor of speech. Virtually all people with PDS have the ability to speak completely fluently at times and in certain situations. If you mix their fluent speech samples with samples of normal speakers, I bet with you that a listener will not be able to distinguish between the two groups. So we do have the ability to speak, and we are not like some people who cannot pronounce certain sounds or control their speech rate. Concerning language, no-one to my knowledge has ever shown that people with PDS have clear language deficits (like in dyslexia), but possibly very subtle ones.
But to what brain function does PDS link if not language or speech? My answer is that PDS is not a total breakdown of a brain function, but only an unstable underperforming brain function. Moreover, PDS is probably not about a specific brain function, but about the malfunctioning interplay between different brain functions, probably the integration between different information from different brain regions. In a sense, it is in between speech and language.
I am finished with drugs
I have been writing a lot about drugs for treating PDS, and this post is going to be the last for a while.
My blog is getting a bit too interactive! Yesterday I received an email by a prospective participant of the Paraglone study. For the sake of science, I should probably not speculate about the study until its end. However, as the study is very likely a double blind study, I guess writing on a blog about the subject and "experimental subjects" reading the posts does not bias the results?
Holger Stenzel provided me with more information on drugs & PDS, only enhancing his junkie status! :-) I am just kidding. In my opinion, he deals with the issue in a frightfully rational and responsible way. He told me and I read about his experience with two drugs: Risperidone and Olanzapine. He took the medication under the supervision of a neurologist. He discontinued use of Risperidone after only a brief period, and has been taking Olanzapine for two and a half years, but is now only taking it every second day. He has spoken about his experience in German discussion forums, and made his reports available to researchers and pharmaceutical companies. To summarise, he says that he has been noticeably more fluent (he talks about a reduction of 30%) but with some side effects. He also said that the German discussion forums have been quite ideological about his reports/work. I have read his posts, but I wholeheartedly support him, as his descriptions and review of the literature strikes me as very objective and informed. In fact, I was wondering myself whether, given the opportunity, I would try a drug myself.
Holger has also sent me links to two interesting articles: on Olazapine, and a review by Maguire and others.
He also told me about this on-going "pilot study of the efficacy and safety of Aripiprazole in the treatment of stuttering (co-PI), 2004 to 2005." (check here) Aripiprazole was developed by Britol-Myers Squibb Company to treat schizophrenia. Its effects are novel in the sense that it is not only antagonistic to dopamine receptors, but can be partially agonistic in case of lower-than-normal activity. Therefore, a stabilisation of the neurotransmitter system is expected.
The Department of Psychiatry and Human Behavior from the University of California at Irvine has a budget of $5 million dollar to work together with pharmaceutical companies on Phase I-III Clinical Trials, among them on PDS.
My blog is getting a bit too interactive! Yesterday I received an email by a prospective participant of the Paraglone study. For the sake of science, I should probably not speculate about the study until its end. However, as the study is very likely a double blind study, I guess writing on a blog about the subject and "experimental subjects" reading the posts does not bias the results?
Holger Stenzel provided me with more information on drugs & PDS, only enhancing his junkie status! :-) I am just kidding. In my opinion, he deals with the issue in a frightfully rational and responsible way. He told me and I read about his experience with two drugs: Risperidone and Olanzapine. He took the medication under the supervision of a neurologist. He discontinued use of Risperidone after only a brief period, and has been taking Olanzapine for two and a half years, but is now only taking it every second day. He has spoken about his experience in German discussion forums, and made his reports available to researchers and pharmaceutical companies. To summarise, he says that he has been noticeably more fluent (he talks about a reduction of 30%) but with some side effects. He also said that the German discussion forums have been quite ideological about his reports/work. I have read his posts, but I wholeheartedly support him, as his descriptions and review of the literature strikes me as very objective and informed. In fact, I was wondering myself whether, given the opportunity, I would try a drug myself.
Holger has also sent me links to two interesting articles: on Olazapine, and a review by Maguire and others.
He also told me about this on-going "pilot study of the efficacy and safety of Aripiprazole in the treatment of stuttering (co-PI), 2004 to 2005." (check here) Aripiprazole was developed by Britol-Myers Squibb Company to treat schizophrenia. Its effects are novel in the sense that it is not only antagonistic to dopamine receptors, but can be partially agonistic in case of lower-than-normal activity. Therefore, a stabilisation of the neurotransmitter system is expected.
The Department of Psychiatry and Human Behavior from the University of California at Irvine has a budget of $5 million dollar to work together with pharmaceutical companies on Phase I-III Clinical Trials, among them on PDS.
Monday, August 22, 2005
Timeline of Pagoclone study
Several of you have asked me about whether I know the timeline of the Pagoclone study: see Indevus' website, and a previous post.
I have been told that the study is starting now, and expected to be finished within less than a year. So we are looking at late Spring or Summer 2006 for the earliest date of the results to be made public.
General speaking, the pharmaceutical industry is under pressure to publish the results even if it turns out to be negative.
So we need to wait.........
I have been told that the study is starting now, and expected to be finished within less than a year. So we are looking at late Spring or Summer 2006 for the earliest date of the results to be made public.
General speaking, the pharmaceutical industry is under pressure to publish the results even if it turns out to be negative.
So we need to wait.........
Friday, August 19, 2005
Tom's Top 10 on drugs
Here are some thought provoking statements about using drug for PDS treatment.
1) Drugs will never cure PDS.
2) Studies will show that some drugs reduce stuttering symptoms in the majority of people with PDS.
3) Drugs will be less effective for some, probably allowing scientists to divide people with PDS into subclasses which would be a very significant finding.
4) Studies will also show that there are no long-lasting effects once drug use is discontinued.
5) The most useful and effective use will be temporally limited to a few hours i.e. taken before an important presentation or job interview.
6) The drugs will have no significant side effects.
7) The class(es) of drugs most effective will give us a better understanding of the nature and causes of PDS.
8) Drugs that do not alleviate symptoms but might help to unlearn bad habits, learn new habits or prevent relapse will become as important as drugs alleviating symptoms.
9) Pharmaceutical companies might jump on the band wagon depending on the strength of the business cases. Leading to more money for *real and no nonsense* scientific research and to aggressive marketing, and in the process to an over-emphasizing of the real usefulness.
10) The use of drugs that act more with the fear/anxiety aspects or that will be taken over long periods of time will stay problematic both medically and ethically.
1) Drugs will never cure PDS.
2) Studies will show that some drugs reduce stuttering symptoms in the majority of people with PDS.
3) Drugs will be less effective for some, probably allowing scientists to divide people with PDS into subclasses which would be a very significant finding.
4) Studies will also show that there are no long-lasting effects once drug use is discontinued.
5) The most useful and effective use will be temporally limited to a few hours i.e. taken before an important presentation or job interview.
6) The drugs will have no significant side effects.
7) The class(es) of drugs most effective will give us a better understanding of the nature and causes of PDS.
8) Drugs that do not alleviate symptoms but might help to unlearn bad habits, learn new habits or prevent relapse will become as important as drugs alleviating symptoms.
9) Pharmaceutical companies might jump on the band wagon depending on the strength of the business cases. Leading to more money for *real and no nonsense* scientific research and to aggressive marketing, and in the process to an over-emphasizing of the real usefulness.
10) The use of drugs that act more with the fear/anxiety aspects or that will be taken over long periods of time will stay problematic both medically and ethically.
The German stuttering junkie
Holger Stenzel has posted an interesting comment in German, so I decided to translate it in English so you can read it.
I have never met Holger, but several people kind of jokingly refer to him as the German stuttering junkie :-), as he is very knowledgable on this issue, has been and is discussing the issue in German discussion groups and, I think, also wrote about his experience with some of the drugs, but I couldnt find anything on google.
Here is the text.
"The good and bad days effect seems to be shared by many people with PDS according to testimony.
My personal symptoms are also marked by constantly changing phases of better or worse fluency. I find it very difficult to causally link them to other factors. Except that good days in terms of fluency seems to go hand in hand with better cognitive performance in word retrieval and concentration, and during bad days I often experience that any attempt to speak creates havoc in my brain.
It is plausible that the effect is related to specific constellations of the neurotransmitter metabolism. Finding the underlying biochemical mechanism could provide the necessary basis to develop drugs that would so-to-speak keep the good days permamently. This approach should be feasible and would be an important step in a medical treatment of stuttering.
Currently, neuropharmaceutical understanding of stuttering is not sufficiently good. An inhibiting factor is the very limited ability of test any drug for speech and cognition using animal models. Gerry Maguire et al.'s dopamine [Note: a neurotransmitter] hypothesis is a first step and based on clinical studies of the drug Risperidon and Olanzapin. The dopamine antagonists are the first class of drugs with proven fluency enhancing effects.
A rather unintended discovery was the dramatic reduction in symptoms with some people with PDS taking a derivate of the substance Cyclopyrrolon, Pagoclone. The outcomes of the Phase 2 study by Indevus Pharmaceuticals Inc. are eagerly anticipated. Pagoclone is said to act as an antagist and modulate GABA-A [Note: see here]. The inhibitionary effect of GABA is due to hyperpolarisation. A stream of negatively charges ions blocks the depolarisation of the neuron needed to release the action potential. And that is how GABA reduces the electrical excitibality of neurons. Indevus is the first pharmaceutical company to have apply for a patent for a drug for PDS: see here.
Best wishes from Germany!
Holger Stenzel
holger-stenzel@t-online.de"
(Source: Holger Stenzel, translated by Tom Weidig)
I have never met Holger, but several people kind of jokingly refer to him as the German stuttering junkie :-), as he is very knowledgable on this issue, has been and is discussing the issue in German discussion groups and, I think, also wrote about his experience with some of the drugs, but I couldnt find anything on google.
Here is the text.
"The good and bad days effect seems to be shared by many people with PDS according to testimony.
My personal symptoms are also marked by constantly changing phases of better or worse fluency. I find it very difficult to causally link them to other factors. Except that good days in terms of fluency seems to go hand in hand with better cognitive performance in word retrieval and concentration, and during bad days I often experience that any attempt to speak creates havoc in my brain.
It is plausible that the effect is related to specific constellations of the neurotransmitter metabolism. Finding the underlying biochemical mechanism could provide the necessary basis to develop drugs that would so-to-speak keep the good days permamently. This approach should be feasible and would be an important step in a medical treatment of stuttering.
Currently, neuropharmaceutical understanding of stuttering is not sufficiently good. An inhibiting factor is the very limited ability of test any drug for speech and cognition using animal models. Gerry Maguire et al.'s dopamine [Note: a neurotransmitter] hypothesis is a first step and based on clinical studies of the drug Risperidon and Olanzapin. The dopamine antagonists are the first class of drugs with proven fluency enhancing effects.
A rather unintended discovery was the dramatic reduction in symptoms with some people with PDS taking a derivate of the substance Cyclopyrrolon, Pagoclone. The outcomes of the Phase 2 study by Indevus Pharmaceuticals Inc. are eagerly anticipated. Pagoclone is said to act as an antagist and modulate GABA-A [Note: see here]. The inhibitionary effect of GABA is due to hyperpolarisation. A stream of negatively charges ions blocks the depolarisation of the neuron needed to release the action potential. And that is how GABA reduces the electrical excitibality of neurons. Indevus is the first pharmaceutical company to have apply for a patent for a drug for PDS: see here.
Best wishes from Germany!
Holger Stenzel
holger-stenzel@t-online.de"
(Source: Holger Stenzel, translated by Tom Weidig)
Tuesday, August 16, 2005
Fluctuation over time
Today, it is just a quick post. The post is about the fluctuation of the severity of stuttering over time. Many people including myself experience moments of greater fluency and unfortunately moments of disastrous disfluency. Why? A scientific theory must explain this phenomena. We all go through periods where we are in best form, be it intellectually, mood-wise, or like in sports. Or, for example, people with hearing difficulties also fluctuate in their ability to hear. So this fluctuation in fluency should not come as a surprise, but still the question is what is the exact mechanism that makes us more or less fluent.
Sometimes it could just be day form, but sometimes it seems to be a situation that changes severity dramatically. I am wondering whether much research has been done on this issue. Does the severity have cycles like increasing slowly, peaking and then going down slowly? Or is it more erratic? Changing dramatically within one day. And how much does it fluctuate? Which factors correlate with a change in fluency?
Tom
By the way, I am currently in Munich, and writing this post from the computer of a friend of mine. She actually promised me to read my blog. So if you are reading this: Hello Heike! Do you like my blog? :-)
Sometimes it could just be day form, but sometimes it seems to be a situation that changes severity dramatically. I am wondering whether much research has been done on this issue. Does the severity have cycles like increasing slowly, peaking and then going down slowly? Or is it more erratic? Changing dramatically within one day. And how much does it fluctuate? Which factors correlate with a change in fluency?
Tom
By the way, I am currently in Munich, and writing this post from the computer of a friend of mine. She actually promised me to read my blog. So if you are reading this: Hello Heike! Do you like my blog? :-)
Saturday, August 13, 2005
Too busy to write
I am too busy to write... until next Wednesday....
I have to organise a party for tommorrow evening and then I am off to Munich.
Tom
I have to organise a party for tommorrow evening and then I am off to Munich.
Tom
Friday, August 05, 2005
Neurotransmitters and PDS
Swallow one pill and your stuttering is gone! An attractive thought for most of us who have PDS. No tedious speech exercises or frightening exploration of our inner soul. Over the years many drugs have been tried out to reduce stuttering with mixed results. Some drugs seem to be able to reduce stuttering but not eliminate all dysfluencies. But, the effect is very dependent on the person, and side effects can be severe. In this post, I want to explain why drugs can have an impact on stuttering severity. But please take my expose in with a pinch of salt, I am not an expert.
Broadly speaking, many drugs impact stuttering by directly or indirectly changing the level of (certain types of) neurotransmitters in the brain. Thus, the issue is really about understanding how a change in the level of neurotransmitters can affect stuttering. Neurotransmitters are molecules that relay and modulate the electrical signals between neurons and are therefore able to inhibit or increase the activity of neurons. The mechanism is as follows. Neurons have long arms which end close to other neurons. When a neuron fires an electrical signal, the signal travels along the long arm. At its end due to the electrical signal, neurotransmitters are released and they dock to the receptors on the membrane of the other neuron. This docking provokes changes in the other neuron influencing its probability to fire a signal. Different regions of the brain have different sensitivities to the different types of neurotransmitters. This sensitivity comes from the number of receptors for a specific type of neurotransmitters the membrane of the neurons in that region have.
When I think about neurotransmitters acting on the brain, I think about the weather acting on a big city. Remember I compare the brain to a big city, with many different objects interacting with each other. And the neurotransmitters are the weather that changes the interaction of the objects. For example, during heavy rain fall, the motorways have more traffic jams because the tyres have less grip on the road. Or during suneshine, people are having less stress and work more efficiently. I think of PDS as a defect underground transport system either due to genetics (e.g. a blueprint for underground trains or how to build tunnes is missing) or developmental issues (e.g. the tunnels was never built due to an earthquake or no cash). You can now see how the weather (i.e. the neurotransmitters) can impact the functioning of the city without an underground system. Nice weather makes it easier to function without an underground system. Bad weather like heavy rainfall (i.e. different levels of neurotransmitters due to stress or panic) makes the absence of an underground system much worse. A drug that gives you nice weather makes you stutter less.
After this crude introduction, I will be able to discuss the Pagoclone pharmaceutical study in more detail in my next post.
Broadly speaking, many drugs impact stuttering by directly or indirectly changing the level of (certain types of) neurotransmitters in the brain. Thus, the issue is really about understanding how a change in the level of neurotransmitters can affect stuttering. Neurotransmitters are molecules that relay and modulate the electrical signals between neurons and are therefore able to inhibit or increase the activity of neurons. The mechanism is as follows. Neurons have long arms which end close to other neurons. When a neuron fires an electrical signal, the signal travels along the long arm. At its end due to the electrical signal, neurotransmitters are released and they dock to the receptors on the membrane of the other neuron. This docking provokes changes in the other neuron influencing its probability to fire a signal. Different regions of the brain have different sensitivities to the different types of neurotransmitters. This sensitivity comes from the number of receptors for a specific type of neurotransmitters the membrane of the neurons in that region have.
When I think about neurotransmitters acting on the brain, I think about the weather acting on a big city. Remember I compare the brain to a big city, with many different objects interacting with each other. And the neurotransmitters are the weather that changes the interaction of the objects. For example, during heavy rain fall, the motorways have more traffic jams because the tyres have less grip on the road. Or during suneshine, people are having less stress and work more efficiently. I think of PDS as a defect underground transport system either due to genetics (e.g. a blueprint for underground trains or how to build tunnes is missing) or developmental issues (e.g. the tunnels was never built due to an earthquake or no cash). You can now see how the weather (i.e. the neurotransmitters) can impact the functioning of the city without an underground system. Nice weather makes it easier to function without an underground system. Bad weather like heavy rainfall (i.e. different levels of neurotransmitters due to stress or panic) makes the absence of an underground system much worse. A drug that gives you nice weather makes you stutter less.
After this crude introduction, I will be able to discuss the Pagoclone pharmaceutical study in more detail in my next post.
Thursday, August 04, 2005
Quality stamp against evaluation
A lot of efforts are going into evaluating different therapies. As I have said before, evaluating the efficacy of a therapy is a very tricky business. And comparing therapies is even more difficult. There are many theoretical issues. Let me list a few. The profile of the clients might be different. The quality of therapist might influence the therapy. Can you punish a therapy where the clients did not follow the instructions. The enormous efforts needed to get a sample big enough for reliable statistics. Defining the correct outcome measures. The time period over which the clients need to be monitored. These are a few of the issues from the top of my head. I agree that criticizing is always much easier than making constructive suggestion for improvement! But let me just re-emphasize that I myself had done a statistical study on patients' data of the KST.
Due to the enormous difficulties to have a controlled environment to do measure therapy efficacy, I believe that national associations must be realistic and go the route of quality control rather than evaluation. Instead of evaluating the success of a therapy, the associations could give out a "quality stamp", a kind of seal of approval. Therapies must fufill certain quality criteria to obtain the "quality stamp". My suggestions would be, for example: The therapy is fully documented. The patients are informed about the latest understanding of PDS. The patients are told that a cure as such is unlikely but a significant improvement with hard work is possible. The therapy has a maintenance phase of at least one year. The therapy or therapist must exist for at least one year. And so on.
So what is your opinion? I think such an approach is doable, even though much work and lobbying would need to be done...
Due to the enormous difficulties to have a controlled environment to do measure therapy efficacy, I believe that national associations must be realistic and go the route of quality control rather than evaluation. Instead of evaluating the success of a therapy, the associations could give out a "quality stamp", a kind of seal of approval. Therapies must fufill certain quality criteria to obtain the "quality stamp". My suggestions would be, for example: The therapy is fully documented. The patients are informed about the latest understanding of PDS. The patients are told that a cure as such is unlikely but a significant improvement with hard work is possible. The therapy has a maintenance phase of at least one year. The therapy or therapist must exist for at least one year. And so on.
So what is your opinion? I think such an approach is doable, even though much work and lobbying would need to be done...
Wednesday, August 03, 2005
Battle of the Therapies
Which form of therapy is the best? Answering such an explosive question is not easy, and might even be impossible when including practical considerations on costs, logistics, therapist-dependent-outcome and even defining outcome measures. I do not know of any published serious research comparing different therapies with enough clients to do decent statistics.
To my knowledge, PEVOS from the Demosthenes Institute of the German Stuttering Association is the only such attempt currently running. The Demosthenes institute deals with educational and research issues on PDS. PEVOS stands for "project of evaluation of stuttering therapies". The linked webpage is in German. They have written an English article for a forum discussion at the ISAD 2003: look here.
They write in the abstract: "On the initiative of the German self-help organisation the PEVOS program was developed to evaluate different stuttering therapies over a time period of two years after therapy. The concept was designed by a group of therapists and scientists and was tested since 2001. In the test-phase data were collected from ten therapists with 100 clients. Fluency data were obtained by telephone calls. Functional outcomes and changes in attitudes and emotions were measured with questionnaires. Results of the test-phase¹s evaluation including the first two assessments will be presented, organisational problems and possible solutions will be discussed."
Their results do not suprise me, and confirm what many have found before. The clients have on average significantly improved in fluency. Unfortunately, they do not have long-term data yet. At least one-year data is needed to evaluate the success of a therapy. They have also not compared between therapies for example, but such a comparison might not be very meaningful until long-term data is available. They are refreshingly frank about the difficulties that they faced. They conclude: "In addition the program is very time-consuming and therefore expensive. PEVOS has been financed by the German stuttering association during the test-phase and its follow-ups. Several unsuccessful attempts have been made to secure funding for the main implementation of PEVOS. Considering these failed attempts it is necessary to think the concept over: it must be considered that therapists and/or professional associations of therapists contribute to the costs. At the same time it must be considered how the program could be less time-consuming." Unfortunately, the issues (e.g. of data collection) will only get worse as time from end of therapy (to get the long-term data) will increase. And I can think of other important theoretical issues that they have not even discussed... It is very very tricky to do the research sensibly... But they should be applauded for their efforts and courage to launch such a project! I am more of an advocat for a "quality stamp" approach by national assocations than evaluation which is difficult, tricky and messy. Such an approach would entail a checklist of features a "good" therapy should have: giving information on PDS, maintenance phase, no claim of a cure, etc.
The article was as of End of 2003. A new statistical study of the current PEVOS data (which should include more long-term data) is underway, and new results should be out in a few months.
To my knowledge, PEVOS from the Demosthenes Institute of the German Stuttering Association is the only such attempt currently running. The Demosthenes institute deals with educational and research issues on PDS. PEVOS stands for "project of evaluation of stuttering therapies". The linked webpage is in German. They have written an English article for a forum discussion at the ISAD 2003: look here.
They write in the abstract: "On the initiative of the German self-help organisation the PEVOS program was developed to evaluate different stuttering therapies over a time period of two years after therapy. The concept was designed by a group of therapists and scientists and was tested since 2001. In the test-phase data were collected from ten therapists with 100 clients. Fluency data were obtained by telephone calls. Functional outcomes and changes in attitudes and emotions were measured with questionnaires. Results of the test-phase¹s evaluation including the first two assessments will be presented, organisational problems and possible solutions will be discussed."
Their results do not suprise me, and confirm what many have found before. The clients have on average significantly improved in fluency. Unfortunately, they do not have long-term data yet. At least one-year data is needed to evaluate the success of a therapy. They have also not compared between therapies for example, but such a comparison might not be very meaningful until long-term data is available. They are refreshingly frank about the difficulties that they faced. They conclude: "In addition the program is very time-consuming and therefore expensive. PEVOS has been financed by the German stuttering association during the test-phase and its follow-ups. Several unsuccessful attempts have been made to secure funding for the main implementation of PEVOS. Considering these failed attempts it is necessary to think the concept over: it must be considered that therapists and/or professional associations of therapists contribute to the costs. At the same time it must be considered how the program could be less time-consuming." Unfortunately, the issues (e.g. of data collection) will only get worse as time from end of therapy (to get the long-term data) will increase. And I can think of other important theoretical issues that they have not even discussed... It is very very tricky to do the research sensibly... But they should be applauded for their efforts and courage to launch such a project! I am more of an advocat for a "quality stamp" approach by national assocations than evaluation which is difficult, tricky and messy. Such an approach would entail a checklist of features a "good" therapy should have: giving information on PDS, maintenance phase, no claim of a cure, etc.
The article was as of End of 2003. A new statistical study of the current PEVOS data (which should include more long-term data) is underway, and new results should be out in a few months.
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