Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

— ORBITOC3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934007
• Other study ID #: 2017-A02544-49
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Ghina Harika-Germaneau, MD, PhD
• Phone: +33 5 16 52 61 18
• Email: ghina.harika.germaneau[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 31, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• rTMS Treatment
1 Hz rTMS

Locations

Country	Name	City	State
France	Sorbonne University, Pitié-Salpêtrière Hospital	Paris
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

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