Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: rTMS Treatment

• Registration Number: NCT04934007
• Lead Sponsor: Centre Hospitalier Henri Laborit

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Study Start: 2021-09-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-07-02
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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 0.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active stimulation	rTMS Treatment	Active rTMS stimulation , 2 session per day during 10 days.
Sham Stimulation	rTMS Treatment	Sham rTMS stimulation , 2 session per day during 10 days.

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale score	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 Outcome Measures

Name	Time	Method
general assessement functioning (GAF)	baseline and 70 days	Change of the general assessement functioning (GAF) at day 70
Clinical Global Impression (CGI)	baseline and 70 days	Clinical Global Impressions (CGI) change at day 70
Adverse events linked to the rTMS treatment	70 days	Number and types of adverse events linked to the rTMS treatment
Yale Brown Obsessive Compulsive Scale	baseline and 70 days	Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70

Trial Locations

Locations (2)

Sorbonne University, Pitié-Salpêtrière Hospital; 🇫🇷 Paris, France

Centre Hospitalier Henri Laborit; 🇫🇷 Poitiers, France