ORBITOC3: Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

• Sponsor: Centre Hospitalier Henri Laborit (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04934007
• Collaborator: (none)
• Enrollment: 136
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 27.8
• Patients Per Site: 68
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Device: rTMS Treatment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
• Actual Study Start Date: Sep 6, 2021
• Anticipated Primary Completion Date: Aug 2, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Yale Brown Obsessive Compulsive Scale [baseline and 70 days]

   Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70

2. general assessement functioning (GAF) [baseline and 25 days]

   Change of the general assessement functioning (GAF) at day 25

3. general assessement functioning (GAF) [baseline and 70 days]

   Change of the general assessement functioning (GAF) at day 70

4. Clinical Global Impression (CGI) [baseline and 25 days]

   Clinical Global Impressions (CGI) change at day 25

5. Clinical Global Impression (CGI) [baseline and 70 days]

   Clinical Global Impressions (CGI) change at day 70

6. Adverse events linked to the rTMS treatment [70 days]

   Number and types of adverse events linked to the rTMS treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sorbonne University, Pitié-Salpêtrière Hospital	Paris		France
2	Centre Hospitalier Henri Laborit	Poitiers		France	86021

Sponsors and Collaborators

• Centre Hospitalier Henri Laborit

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Henri Laborit
• ClinicalTrials.gov Identifier: NCT04934007
• Other Study ID Numbers: 2017-A02544-49
• First Posted: Jun 22, 2021
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Henri Laborit: rTMS; D-B80 A/P
• Additional relevant MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Dec 16, 2021