Using rTMS on the Orbito Frontal Cortex for Obsessive-Compulsive Disorder
A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
This study is testing whether a new brain stimulation treatment can help adults with obsessive-compulsive disorder who haven't found relief from other medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Henri Laborit Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT04934007 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of repetitive Trans-cranial Magnetic Stimulation (rTMS) targeting the lateral part of the Orbito Frontal Cortex (lOFC) in patients diagnosed with Obsessive-Compulsive Disorder (OCD). Participants, aged 18-65, must have previously failed to respond to at least two different pharmacological treatments. The study aims to assess the efficacy of this non-invasive brain stimulation technique in alleviating OCD symptoms. The trial will be conducted at multiple locations, including Sorbonne University and Pitié-Salpêtrière Hospital in Paris.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of OCD who have not benefited from at least two prior pharmacological treatments.
Not a fit: Patients with other significant psychiatric disorders, active medical illnesses, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new non-pharmacological option for patients with OCD who have not responded to traditional medications.
How similar studies have performed: Previous studies have shown promising results using rTMS for OCD, indicating that this approach is supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris and 1 other locations
- Sorbonne University, Pitié-Salpêtrière Hospital — Paris, France (Recruiting)
- Centre Hospitalier Henri Laborit — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Ghina Harika-Germaneau, MD, PhD
- Email: ghina.harika.germaneau@ch-poitiers.fr
- Phone: +33 5 16 52 61 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.