Study Seeks Longer-Term Benefits From Tourette Treatment
Tourette syndrome (TS) is a neurodevelopmental condition
that affects nearly 1 percent of children worldwide. While it can be treated
with drugs and behavioral therapy, other modalities are being sought,
especially in cases that are resistant to standard treatment. Keith Coffman,
MD, Director of Tourette Syndrome Center of Excellence at Children’s Mercy
Kansas City, is leading the way with a study designed to better understand the
long-term effectiveness of multisite transcranial magnetic stimulation (mTMS)
TMS is already FDA-approved for treatment of depression and
obsessive-compulsive disorder. It’s also used in various clinical studies to
better understand its effectiveness in controlling Tourette syndrome symptoms.
In these studies, magnetic stimulation is performed using a hand-held device
that is bulky, delivers a high level of current that can cause unpleasant
sensations, and can provide stimulation at only one cortical site at a time.
Some studies using this device have shown promising results, but the benefits
have worn off because patients were unable to keep a regular schedule of
hospital visits for access to the device...
The Evolution of Technology
A new portable device has been developed and patented by Dr.
Santosh Helekar of Houston Methodist Research Institute (HMRI) and Dr. Henning
Voss of Weill-Cornell Medical College (WCMC). The only device of its kind in
the U.S., it’s smaller and wearable and can deliver stimuli at multiple
cortical sites simultaneously or sequentially.
It uses rapidly rotating, small, high-strength permanent
magnets to induce currents in the brain. This device delivers lower levels of
current during stimulation, eliminating the discomfort common in other TMS
devices. Best of all, it can be used at home, making it more practical. This
device is the cornerstone of Dr. Coffman’s study.
Setting Goals for the Study
Dr. Coffman’s study is testing the therapeutic effectiveness
of bilateral mTMS of the supplementary motor areas (mTMS-SMA therapy) in TS
patients presenting with tics uncontrolled by standard drug and behavioral
treatment.
Two types of devices will be used: One is real and the other
is a sham device. Only the manufacturer knows the difference. Patients are
randomized at enrollment in a placebo-controlled fashion.
The specific aims of this study are:
To compare the immediate benefits experienced by TS patients
subjected to stimulation to the TS patients receiving placebo treatment, in
terms of reduction of the frequency of tics and alleviation (primary end
points) of other comorbidities (ADHD and OCD, secondary end points) of TS.
To compare the long-term benefits over a two-month follow-up
period in the same set of treated and placebo control TS patients.
Criteria for Participation
To be considered for the study, a patient must meet these
criteria:
Meet a specific threshold on the Yale Global Tic Severity
Scale (YGTSS) in order to show a drop in baseline level of symptoms.
Cannot have epilepsy, due to seizure risk from stimulation.
No implanted devices in body, such as vagal nerve
stimulator, cochlear implants or intracranial hardware.
Study Design
The study period is 10 days, with five consecutive days of
mTMS per week for two weeks.
Each session lasts one hour.
Symptom levels are assessed at enrollment and periodically
during the treatment.
Patients are assessed again at follow-up visits two weeks
and one month post-treatment.
Patients are also assessed for changes in levels of anxiety,
ADHD symptoms and obsessive-compulsive symptoms.
Results
Dr. Coffman and his team are enrolling patients currently.
Study details are listed on clinicaltrials.gov, where providers and patients’
families can find enrollment details. Once the entire cohort has been enrolled
and treated, results will be available several months later.
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