Obsessive Compulsive Disorder Clinical Trial
Official title:
Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome.
This is an open study.approximately 20 patients diagnosed with tourette's syndrome and under
pharmAcological or psychotherapy treatments will participate.patients will be recruited from
Schneider hospital and all his extensions. subjects would undergo rTMS (repetitive
Transcranial Magnetic Stimulation) for five days a week, for four weeks,and will be
clinically evaluated in order to monitor for improvement.
We anticipate a significant reduction in symptoms severity at the end of the treatment
compared to study entry.
Tourette's syndrome is a developmental neuropsychiatric disorder which is characterized by
stereotypical motor and verbal bursts that are called Tics.
There is a small number of treatments that are available for the disorder, most of them are
pharmacological agents that have serious side effects and are not very efficient in treating
it.
In this current study we are attempting to find a better solution for the treatment of
tourette syndrome using deep Transcranial magnetic stimulation(dTMS) technology.our region
of interest for stimulation is the supplementary motor cortex (SMA). earlier superficial TMS
studies focusing on the SMA have shown promising results. In theses studies clinical
improvement was evident after two weeks of treatment, and for some of the subjects it was
even maintained for a period of 3 months.we are using a similar protocol of TMS stimulation
used in a study by Mantovani et al (2006).The protocol includes bilateral stimulation to the
SMA at 110% of the motor threshold of the Abductor Policies Brevis and at a frequency of 1
Hz. each session is comprised of four cycles of 5 minutes of stimulation and a 2 minute
recess.approximately 20 patients diagnosed with tourette syndrome and under pharmAcological
or psychotherapy treatments will participate. patients will be recruited from Shnider
hospital and all his extensions subjects would undergo rTMS sessions for five days a week,
for four weeks, using the HBDL dTMS coil. this coil is capable of producing a magnetic field
in deeper parts of the cerebral cortex, and for that reason we believe that it can produce
better clinical outcomes then superficial TMS coils (such as the figure 8) used in past
studies.
Clinical evaluation includes Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) , Yale
Global Tic Severity rating Scale (YGTSS), Clinical Global Impression (CGI), Beck Depression
Inventory (BDI), Symptoms Check List (SCL-90), Social Adaptation Self evaluation Scale
(SASS), Hamilton Depression Rating Scale (HDRS-24), Hamilton Anxiety Rating Scale (HARS-14),
Beck Depression Inventory (BDI) .These evaluation will be conducted on study entry, 2 weeks
after study entry, at the end of the treatment phase and at a 2 week follow up visit (a
total of four times). Further more, clinical evaluation will be administrated at Schneider
hospital, while treatments are conducted at the cognitive lab at Shalvata hospital.
Our main objective is to observe a reduction in the severity of the symptoms post treatment
in comparison to pre treatment, using the YGTSS as the main outcome measure.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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