Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active stimulation

Active rTMS stimulation , 2 session per day during 10 days.

Group Type EXPERIMENTAL

rTMS Treatment

Intervention Type DEVICE

1 Hz rTMS

Sham Stimulation

Sham rTMS stimulation , 2 session per day during 10 days.

Group Type SHAM_COMPARATOR

rTMS Treatment

Intervention Type DEVICE

1 Hz rTMS

Interventions

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rTMS Treatment

1 Hz rTMS

Intervention Type DEVICE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No