Actively Recruiting
A Randomized Control Trial of Bilateral Lateral Orbito Frontal Cortex rTMS in Obsessive Compulsive Disorder
Led by Centre Hospitalier Henri Laborit · Updated on 2026-01-13
136
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of bilateral lateral Orbito Frontal Cortex (lOFC) repetitive Trans-cranial Magnetic Stimulation (rTMS) in adults aged 18 to 65 with Obsessive Compulsive Disorder (OCD). This study evaluates rTMS as a treatment by targeting both hemispheres of the lOFC, an area shown to be relevant for OCD symptoms. Participants included have not responded to at least two pharmacological treatments for their condition. Participants are randomly assigned to one of two groups: one receiving active rTMS stimulation and the other receiving sham (placebo) stimulation. Both groups undergo two rTMS sessions per day over a period of 10 days. The treatment uses 1 Hz rTMS, a device-based brain stimulation method, applied bilaterally to the lateral OFC. During the study, participants will be assessed using the Yale Brown Obsessive Compulsive Scale at baseline, 25 days, and 70 days to measure OCD symptoms. Additional evaluations include the General Assessment of Functioning (GAF) and Clinical Global Impression (CGI) at similar time points. Safety is monitored by recording any adverse events linked to the rTMS treatment. The total study duration includes follow-up assessments up to 70 days after treatment begins.
CONDITIONS
Brief Title
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be males or females aged 18 to 65 years
- Diagnosis of Obsessive Compulsive Disorder (OCD)
- Have failed to respond to at least two different pharmacological treatments used for at least 6 weeks
- Affiliation to a social security system (recipient or assignee)
- Signed written informed consent form
You will not qualify if you...
- Diagnosis of another psychiatric disorder except anxiety disorders
- Significant active medical illness
- Pregnancy or nursing
- Neurological illness
- History of seizures
- Presence of pacemakers, mobile metal implants, implanted medical pumps, or metal clips inside the skull
- Medication changes during the trial; treatment must be stable for at least 3 weeks before day 0
- Female participants of child-bearing age who are sexually active and not using reliable contraception
- Patients under curatorship
- Patients hospitalized under duress
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive bilateral lateral orbito frontal cortex rTMS treatment with 2 sessions per day for 10 days.
Daily visits for 10 days
Duration - Up to 60 days after treatment
Participants are assessed for outcomes and adverse events following treatment.
2 visits (at 25 days and 70 days post-baseline)
Trial Site Locations
Total: 2 locations
1
Sorbonne University, Pitié-Salpêtrière Hospital
Paris, France
Actively Recruiting
2
Centre Hospitalier Henri Laborit
Poitiers, France, 86021
Actively Recruiting
Research Team
G
Ghina Harika-Germaneau, MD, PhD
N
Nematollah Jaafari, PR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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