An interventional study of Active DTMS Treatment and Sham Treatment in Obsessive Compulsive Disorder, sponsored by Brainsway. Completed at 12 sites in 3 countries. Open to participants aged 22 Years to 68 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Brainsway · Not applicable, Interventional, and Treatment
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.
606 studies on the registry are indexed under Obsessive-Compulsive Disorder; 160 are open to participants now.
This study's enrollment of 100 is above the median of 45 across 492 interventional studies indexed under Obsessive-Compulsive Disorder.
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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
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
H-coil Deep TMS 29 TMS treatments over 6 weeks.
29 treatments over 6 weeks.
Also known as: Deep TMS Sham treatment
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.
Time frame: 6 Weeks
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.
Time frame: 6 Weeks and 10 weeks
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: * 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).
Time frame: 10 Weeks
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Obsessive-Compulsive Disorder→
Brainsway