NCT04934007RecruitingNot Applicable
A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Centre Hospitalier Henri Laborit3 sites in 1 country136 target enrollmentStarted: September 6, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 136
- Locations
- 3
- Primary Endpoint
- Yale Brown Obsessive Compulsive Scale score
Study Overview
Brief Summary
According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: Participants will be both males and females, 18-65 years of age included.
- •diagnosis of OCD
- •all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks
- •Affiliation to a social security system (recipient or assignee),
- •Signed written inform consent form
Exclusion Criteria
- •The exclusion criteria are a diagnosis of another psychiatric disorder (except for anxious disorders), a diagnosis of a significant active medical illness, pregnancy or other neurological illness
- •In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded
- •The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day
- •Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
- •Patient under curators
- •Patient hospitalized under duress
- •Patient unable to give his or hers informed consent
Arms & Interventions
Active stimulation
Experimental
Active rTMS stimulation , 2 session per day during 10 days.
Intervention: rTMS Treatment (Device)
Sham Stimulation
Sham Comparator
Sham rTMS stimulation , 2 session per day during 10 days.
Intervention: rTMS Treatment (Device)
Outcomes
Primary Outcomes
Yale Brown Obsessive Compulsive Scale score
Time Frame: baseline and 25 days
Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25
Secondary Outcomes
- general assessement functioning (GAF)(baseline and 70 days)
- Clinical Global Impression (CGI)(baseline and 70 days)
- Adverse events linked to the rTMS treatment(70 days)
- Yale Brown Obsessive Compulsive Scale(baseline and 70 days)
- general assessement functioning (GAF)(baseline and 25 days)
- Clinical Global Impression (CGI)(baseline and 25 days)
Investigators
Study Sites (3)
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