Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome
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|ClinicalTrials.gov Identifier: NCT00965211|
Recruitment Status : Unknown
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was: Recruiting
First Posted : August 25, 2009
Last Update Posted : January 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Tourette's Syndrome Obsessive Compulsive Disorder||Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for the Treatment of Tourette Syndrome.|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2013|
- Device: HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)
a session of rdTMS includes 4 cycles of 5 minutes of stimulation at a frequency of 1 Hz to the supplementary motor cortex and then a 2 minute recess.each subject would undergo 5 sessions a week for 4 weeks.
- The Yale Global Tic Severity rating Scale (YGTSS) [ Time Frame: At study entry and every 2 weeks since then. total of 4 evaluation ]
- Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) [ Time Frame: At study entry and every 2 weeks since. A total of 4 evaluation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965211
|Contact: Eiran Vadim Harel, MD||09-7478644 ext firstname.lastname@example.org|
|Shalvata Mental Health Center||Not yet recruiting|
|Hod Hasharon, Israel|
|Principal Investigator: Eiran Vadim Harel, MD|
|Shalvata Mental Health Center||Recruiting|
|Hod Hasharon, Israel|
|Contact: Hilik Levkovitz, prof. 972-9-7478568 email@example.com|
|Principal Investigator:||Eiran Vadim Harel, MD||Shalvata MHC|