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The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS) treatment in subjects with OCD. The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS treatment to sham treatment.
The OCD study will compare one group of OCD subjects receiving DTMS treatment (HAC-coil) to a second group of OCD subjects receiving sham treatment (sham coil). The treatment group will receive 5 weeks of daily DTMS treatments followed by 4 treatments in week 6, for a total of 29 treatment sessions. The control group will receive the same treatments with a sham coil. Subjects may continue to take SSRI medications (if prescribed) and any other antidepressant medications will be tapered down prior to the first treatment. SSRI medications approved for OCD include Fluoxetine (Prozac, Sarafem, Symbyax), Fluvoxamine (Luvox, Luvox CR), Paroxetine (Paxil, Paxil CR, Pexeva) and Sertraline (Zoloft). Efficacy will be assessed using the Yale-Brown Obsessive Compulsive Scale score (YBOCS), as well as other efficacy scales. Safety will be assessed by monitoring of adverse events, vital signs, physical and neurological examination and using certain safety questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active DTMS Treatment | Active Comparator | 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. |
|
| Sham Treatment | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active DTMS Treatment | Device | H-coil Deep TMS 29 TMS treatments over 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS) score | 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. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS), Sheehan Disability Scale (SDS), Clinical Global Impression - Severity Scale (CGI-S), Clinical Global Impression - Improvement Scale (CGI-I) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events, changes in vitals signs, physical and neurological results, changes in suicide scale and changes in cognitive scales | 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:
|
Inclusion Criteria:
- • Outpatients
Exclusion Criteria:
- • Subjects diagnosed according to the SCID I as suffering from any other Axis I diagnosis as the primary diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Zohar, Prof | Tel Hashomer Hospital | Principal Investigator |
| Abraham Zangen, Prof | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California (UCLA) | Los Angeles | California | 90095 | United States | ||
| University of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32380442 | Derived | Harmelech T, Tendler A, Roth Y, Zangen A. Do comorbid OCD-MDD patients need two separate dTMS protocols? Brain Stimul. 2020 Jul-Aug;13(4):1000-1001. doi: 10.1016/j.brs.2020.03.014. Epub 2020 Mar 31. No abstract available. | |
| 31581800 | Derived | Crowell AL, Riva-Posse P, Holtzheimer PE, Garlow SJ, Kelley ME, Gross RE, Denison L, Quinn S, Mayberg HS. Long-Term Outcomes of Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Depression. Am J Psychiatry. 2019 Nov 1;176(11):949-956. doi: 10.1176/appi.ajp.2019.18121427. Epub 2019 Oct 4. |
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| Sham Treatment |
| Device |
29 treatments over 6 weeks. |
|
|
| 6 Weeks and 10 weeks |
| 10 Weeks |
| San Diego |
| California |
| 92093 |
| United States |
| University of Florida College of Medicine | Gainesville | Florida | 32603 | United States |
| Advanced Mental Health Care Inc. - Juno Beach | Juno Beach | Florida | 33408 | United States |
| Advanced Mental Health Care Inc. - Royal Palm Beach | Royal Palm Beach | Florida | 33411 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Neuropharmacology Services | New York | New York | 10021 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| TMS Hope Center of Long Island | New York | New York | 11777 | United States |
| Lindner Center of HOPE, University of Cincinnati College of Medicine | Mason | Ohio | 45040 | United States |
| Center for Addiction and Mental Health (CAMH) | Toronto | Ontario | Canada |
| Tel Hashomer Hospital | Tel Litwinsky | 52621 | Israel |
| 31109199 | Derived | Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21. |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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