Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder (ORBITOC3)

A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

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 Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: rTMS Treatment

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghina Harika-Germaneau, MD, PhD; Phone Number: +33 5 16 52 61 18; Email: ghina.harika.germaneau@ch-poitiers.fr
• Study Contact Backup: Name: Nematollah Jaafari, PR; Phone Number: +33 5 16 52 61 18; Email: nemat.jaafari@ch-poitiers.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Sorbonne University, Pitié-Salpêtrière Hospital
    • Contact: Bruno Millet, PR; Email: b.millet@aphp.fr
  • Poitiers, France, 86021
    • Recruiting
    • Centre Hospitalier Henri Laborit
    • Contact: Ghina Harika-Germaneau, MD, PhD; Phone Number: +33 5 16 52 61 18; Email: ghina.harika-germaneau@ch-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active stimulation; Active rTMS stimulation , 2 session per day during 10 days.	Device: rTMS Treatment; 1 Hz rTMS
Sham Comparator: Sham Stimulation; Sham rTMS stimulation , 2 session per day during 10 days.	Device: rTMS Treatment; 1 Hz rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale Brown Obsessive Compulsive Scale score	Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25	baseline and 25 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit
• Investigators: Study Director: Ghina Harika-Germaneau, Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: rTMS; D-B80 A/P
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2017-A02544-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No