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The Stuttering Study
publication date: Apr 18, 2009
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author/source: Shannon Alderman / Staff
Dr. Sambunaris is leading the nation’s first study of stuttering. |
By Shannon Alderman / Staff
This week is national stuttering awareness week.
James Earl Jones, Carly Simon, Winston Churchill, Marilyn Monroe, Lewis Carroll... all of these people led successful lives and they also all stuttered. In fact, stuttering can be traced back to the earliest of times when Demosthenes, a prominent Greek statesman and orator of ancient Athens in the 300's B.C., purportedly tried to control his fluency by speaking with small stones in his mouth. In the present, nearly three million Americans stutter but there is still not an FDA approved medicine to combat the issue. Dr. Angelo Sambunaris, MD, a Dunwoody-based physician and psychiatrist, is the principal investigator and founder of the Atlanta Institute of Medicine & Research and he is hoping to change that.
"Currently, there is no FDA approved treatment for stuttering. Everything out there now includes using medications used to treat other diseases that doctors might try to use in an off label manner to treat stuttering," Dr. Sambunaris said. "But the stuttering study is the first large, multi center double blind placebo control trial with a goal of specifically targeting the symptoms of stuttering." He and his ten person staff are currently participating in the national stuttering study at their Atlanta based clinic by evaluating the safety, tolerability and potential treatment effects of a medication called Pagoclone to determine if it will reduce syllables stuttered.
Dr. Sambunaris is no stranger to medical research. After stints at the National Institutes of Mental Health where he did a research fellowship, as acting medical director of the Neuropsychiatric Research Hospital at St. Elizabeth's in Washington, D.C., and in the pharmaceutical industry learning the nuances of the industry and FDA policies, he opened his clinic in 1998 with the goal of working on " cutting edge new medications that are coming through the development pipeline and working directly with patients while evaluating those new and possibly innovative treatments in a free enterprise organization," he said. "We have developed a reputation as a private but more of an academic research facility. In addition to testing drugs we've also done a lot of methodology studies for pharmaceutical companies where we try to develop new scales, and new rating assessments by using FDA approved medicines and trying to figure out if there a better questionnaire we can create to see if this condition is getting better."
ACCIDENTAL MEDICINE
The national stuttering study began rather accidentally when a group of doctors found that Pagoclone, a medication being tested for anxiety, positively and notably impacted two patients at a clinic in California who's stuttering happened to improve while taking the drug. While the drug did little to alleviate their anxiety, it did improve their speech, Dr. Sambunaris said, but the drug company deemed that study unproductive and put it back on the shelf. "The physician who noticed this change in his stuttering patients followed up with the pharmaceutical company and suggested that this drug made his stuttering patients better." In early 2005, the patent was granted to the pharmaceutical company covering the use of Pagoclone as a therapeutic agent for stuttering in the United States and the national stuttering study was born.
WHAT IS STUTTERING?
According to the National Institute on Deafness and Other Communication Disorders, stuttering is a speech disorder in which sounds, syllables, or words are repeated or prolonged, disrupting the normal flow of speech. "It has nothing to do with one's IQ, one's level of intellect or their socioeconomic status," Dr. Sambunaris said. Though the exact cause of stuttering is still unknown, he said it is more likely that "there might be a damaged speech area in the brain or damaged nerves that control the muscles that normally coordinate the thoughts one wants to turn into words." Regardless of the cause, he said, "society's interpretation of an individual who stutters is that that person is dumb or has some cognitive problems and that is not the case at all."
SIDE EFFECTS MAY INCLUDE
The medicine ads on television have been well parodied and for good reason as a healthy person gaily strolls through a verdant field while a voice in the background says ‘may cause headaches, nausea, dizziness, stomach upset and might possibly even lead to more serious conditions.' It is fair to ponder why a person would want to take a drug that might alleviate one symptom but lead to a host of other problems. Thankfully, in the case of Pagoclone, Dr. Sambunaris said, "So far, in the program we aren't seeing many side effects. It is a relatively benign drug and in the last study we saw that it was benign even as far back as the anxiety studies they first did." That might be because the researchers are dosing patients gradually by bringing the levels of medicine up slowly over time. "The patients don't get to a therapeutic dose on their first dose and I think that helps with letting the body get used to it," he added. In terms of the side effects of Pagoclone, he said, "in general there may be some dizziness or light headiness, upset stomach, maybe dry mouth when taking this drug." But from a statistical perspective, he has also seen improvements in the patients he has treated.
He recalled one patient he worked with in the first stuttering study who stuttered severely. "She liked to give sermons every once in a while at her church but when she would get up in front of the crowd, she would stutter severely through it. The more she stuttered, the more nervous she got and the worse the stuttering was. But after participating in the first study, she reported back to me that she was able to give a sermon. She barely stuttered and her anxiety was also lessened," he said. He also said there were a few people who went through the first study that reported no changes at all. "In those cases, you might wonder then if they were on placebo." He won't learn that until the study is completed but he added that the data over the past couple of years suggests that the drug seems to show cumulative improvement in the patients who take it. "So, the longer you stay on this medication the better you do on it which is different from other medications," he said.
For more information about the stuttering study, visit researchmeds.com or contact the Atlanta Institute of Medicine & Research at 770-817-9200. Additional information about the national study can be found by visiting www.stutteringstudy.com.
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