An Evaluation of the Safety and Efficacy of the dTMS Treatment for OCD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02229903|
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Device: Active DTMS Treatment Device: Sham Treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Double Blind Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (dTMS) in Obsessive-Compulsive Subjects|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Active Comparator: Active DTMS Treatment
Active DTMS Treatment constitutes the Deep Transcranial Magnetci Stimulation (DTMS) which is a new form of TMS which allows direct stimulation of deeper neruonal pathways than the standard TMS. The DTMS coil is designed to allow deeper brain stimulation without significant increase of electric fields included in superficial cortical regions.
Device: Active DTMS Treatment
H-coil Deep TMS 29 TMS treatments over 6 weeks.
Sham Comparator: Sham Treatment
The Sham Treatment consists of an electrical field which cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
Device: Sham Treatment
29 treatments over 6 weeks.
Other Name: Deep TMS Sham treatment
- Yale Brown Obsessive Compulsive Scale (YBOCS) score [ Time Frame: 6 Weeks ]The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the 6 week (post-randomization) visit, between the two treatments groups.
- Yale Brown Obsessive Compulsive Scale (YBOCS), Sheehan Disability Scale (SDS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: 6 Weeks and 10 weeks ]
The secondary effectiveness objectives of the study are:
i. Change from baseline to 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) (and other assessment scale) scores, between treatment groups.
ii. Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups; iii.Partial Response rate at 6 weeks in Yale Brown Obsessive Compulsive Scale (YBOCS) score, between treatment groups; iv. Change from baseline to 10 weeks in above scales. v. Remission rates at 6 weeks between treatment groups.
- Number of adverse events, changes in vitals signs, physical and neurological results, changes in suicide scale and changes in cognitive scales [ Time Frame: 10 Weeks ]
Safety of the DTMS treatment as defined by maintained subject baseline, pre-treatment, physical and neurological examinations and lack of significant increase in suicide ideation measured by:
- Vital signs
- Physical and neurological examination
- Scale for Suicide Ideation
- Cognitive evaluation using the Mini-Mental State Exam (MMSE), Buschke Selective Reminding Test (BSRT) and Autobiographical Memory Interview - Short Form (AMI-S) scales
- Any other adverse events (AEs).
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): NCT02229903
|United States, California|
|University of California (UCLA)|
|Los Angeles, California, United States, 90095|
|University of California|
|San Diego, California, United States, 92093|
|United States, Florida|
|University of Florida College of Medicine|
|Gainesville, Florida, United States, 32603|
|Advanced Mental Health Care Inc. - Juno Beach|
|Juno Beach, Florida, United States, 33408|
|Advanced Mental Health Care Inc. - Royal Palm Beach|
|Royal Palm Beach, Florida, United States, 33411|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, New York|
|New York, New York, United States, 10021|
|Mount Sinai Hospital|
|New York, New York, United States, 10029|
|TMS Hope Center of Long Island|
|New York, New York, United States, 11777|
|United States, Ohio|
|Lindner Center of HOPE, University of Cincinnati College of Medicine|
|Mason, Ohio, United States, 45040|
|Center for Addiction and Mental Health (CAMH)|
|Toronto, Ontario, Canada|
|Tel Hashomer Hospital|
|Tel Hashomer, Israel, 52621|
|Principal Investigator:||Joseph Zohar, Prof||Tel Hashomer Hospital|
|Principal Investigator:||Abraham Zangen, Prof||Soroka University Medical Center|