Actively Recruiting
Accelerated BrainsWay Deep Transcranial Magnetic Stimulation Protocol in Obsessive-Compulsive Disorder: A Prospective Double Blind Randomized Controlled Trial
Led by Ben-Gurion University of the Negev · Updated on 2025-08-12
50
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
B
Ben-Gurion University of the Negev
Lead Sponsor
B
Brainsway
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and lasting effects of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in people with Obsessive-Compulsive Disorder (OCD). This randomized, double-blind clinical trial compares active Deep TMS targeting specific brain areas to an inactive sham treatment. The study aims to understand how well this new technology works for OCD symptoms over a 13-week period. Participants receive either active or sham Deep TMS using a special coil that rotates the magnetic field to stimulate brain regions in multiple directions. Treatment involves 39 sessions following an accelerated schedule: an acute phase with daily treatments over one week, a maintenance phase with weekly sessions for five weeks, and a follow-up phase with treatments at weeks 8, 10, and 13. Each treatment day includes three sessions spaced by one hour, lasting about 2.5 hours total. Brain imaging is performed before treatment and after the maintenance phase. During the study, participants undergo clinical assessments including the Yale Brown Obsessive Compulsive Scale (YBOCS) to measure OCD symptoms at 6 and 13 weeks. Researchers monitor adherence to the treatment schedule and safety through various screenings. The study is designed to provide detailed information on the impact of Deep TMS on OCD symptoms and its durability over time.
CONDITIONS
Brief Title
Accelerated Rotational Field Deep TMS for Treating OCD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients
- Diagnosed with Obsessive-Compulsive Disorder according to DSM-V
- Yale Brown Obsessive Compulsive Scale (YBOCS) score greater than 20
- If on serotonin reuptake inhibitors, stable therapeutic dosage for at least 2 months prior to study entry and during the trial
- If receiving cognitive behavioral therapy, must be in maintenance stage with at least ten sessions including exposure and response prevention therapy
- Negative or justified responses to all questions on the Transcranial Magnetic Stimulation Safety Screening questionnaire
- Compliant with medication if applicable as judged by physician
- Capable and willing to provide informed consent and assent
- Willing and able to follow the treatment schedule
- All comorbid diagnoses stable for 3 months and expected to remain stable during 3 months of treatment
You will not qualify if you...
- Primary diagnosis other than Obsessive-Compulsive Disorder
- Unstable secondary psychiatric diagnoses likely requiring treatment changes
- Present suicidal risk or history of suicide attempt within the past year
- History of epilepsy or seizure (except therapeutically induced by ECT or febrile seizures in infancy)
- Increased seizure risk or significant head trauma with loss of consciousness 5 minutes or longer
- History of cranial surgery or prolonged coma due to head injury
- Presence of ferromagnetic or conductive material in head or eyes
- Implanted neurostimulators or intracranial implants
- Significant hearing loss
- Significant neurological disorder or injury
- Substance use disorder within past 6 months except nicotine and caffeine
- Currently in another therapeutic clinical study
- Unstable physical, systemic, or metabolic disorders
- Use of high-dose antidepressants or psychotropic medications lowering seizure threshold, including Clomipramine
- Significant risk of death within 18 months
- Planned surgeries interrupting study schedule within 4 months
- Women who are pregnant, breastfeeding, or not using medically accepted contraception if of childbearing potential and sexually active
- Other conditions deemed exclusionary by investigator or safety screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 13 weeks
Participants receive BrainsWay Deep TMS or sham stimulation following an accelerated protocol consisting of an acute phase, maintenance phase, and follow-up phase over 13 weeks.
5 consecutive daily visits in week 1, weekly visits for 5 weeks during weeks 2-6, and visits at weeks 8, 10, and 13
Duration - Up to 13 weeks total including treatment
Participants undergo assessments including imaging sessions at baseline and at the end of the maintenance phase to monitor treatment effects.
2 imaging visits (baseline and end of maintenance phase)
Trial Site Locations
Total: 1 location
1
Soroka University Medical Center
Beersheba, Israel, 8410101
Actively Recruiting
Research Team
D
Dor Shukrun, PhD Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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