Tourettes Patients Needed for Most Comprehensive Clinical Study Ever Done
New York, New York (PRWEB) January 13, 2015 -- Here is an update on the progress of the TicTocStop (TTS) and University of Tennessee Clinical Study into the efficacy of a patent pending orthotic created to help curb the tics associated with Tourettes. The exciting plans of TTS will offer an opportunity for many patients both kid and adults.
TicTocStop started with a couple of goals in mind. One of them was to help local kids with Tourettes. Although initially self serving, the passion that TTS has, has morphed into something much bigger for all those whose lives are impacted because of Tourette Syndrome. The broader goal of TicTocStop is multifaceted and layered. The first goal is to find a non-pharmaceutical, non-invasive and scalable treatment. The current treatment options are of anti-psychotic drugs, deep brain stimulation is which is not FDA approved and finally CBIT therapy.
According to Dr.Balanoff: "The option of anti-psychotic drugs to treat children was offensive, obtrusive and debilitating. As a parent, medicating your children is always a terrible choice (sometimes necessary but always terrible). Deep brain stimulation is an even poorer option. It is not FDA approved and even if it was, who would subject their children to a glorified lobotomy."
Where does that leave researchers? An oral appliance!
TTS has put together a research team headed up by William L. Balanoff, DDS, MS, FICD. Dr. Balanoff has designed a research project that has the approval and blessing of the FDA. The research involves an oral appliance designed in such a way that it predictably reduces tics (motor and vocal), both in severity and frequency, by at least 30% in a majority of patients. TTS conducted a pilot study where the overall reduction was almost 65%. It was the amazing results of the pilot study that allowed TTS to move forward so quickly with a statistically significant, clinically relevant and comprehensive study. The research is being conducted by the University of Tennessee. The lead investigator is Tim Hottel, DDS, MS, MBA. Dr. Hottel is also the Dean of the dental school at the University of Tennessee, Memphis. The study involves 65 patients (children and adults!) at two different study locations. The second study location is in Long Island. A multi-center study involving 65 patients to test an oral orthotic that will predictably mitigate the physical and clinical manifestations of a neuro-psych disorder such as Tourette Syndrome and Chronic Tic Disorder has never been done. TTS is proud to sponsor this ground breaking research that will help all children and adults who suffer.
Recruiting 65 patients for the study is the difficult part. In the first few weeks many patients have been screened for the study and more than 20 have qualified. TTS needs your help in recruiting patients for the study. Your help can be as simple as referring someone to our web page or as involved as prescreening patient for the study. Can you help?
The study is simple in design. The total study time is 12 weeks and is divided into three phases. The patient wears a placebo appliance for a week and then the active appliance the following week. A Yale Tic Assessment is utilized to monitor and score progress and change (if there is any). The patient continues with the active appliance for an additional 10 weeks at which time the study is over. The patient is paid to participate in the study and is allowed to keep the active appliance at the end of the study.
If the study proves that the appliance can reduce the frequency and severity of tics then the FDA will grant medical clearance for the device. That is a big deal. The next research step is to start to understand why the appliance works. TTS wants to understand what/why there is a reduction in tics. Understanding this will allow better medical screening of young children which would allow for early intervention treatments. The research opportunities are limitless. Best of all, the children and adults whose lives have been impacted by this disease will now have relief.
Imagine if TTS could provide treatment and then help find a cure. The goals of TTS as a foundation are connected spiritually as well as bound by good medicine and science.
The claims made are supported and attributed to Dr. William L. Balanoff, DDS, MS, FICD
Craig Carton, TicTocStop, http://tictocstop.org, +1 2157404703, [email protected]
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