Recruiting NCT04934007
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS Treatment.
- Who it may be relevant to
- Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Overview
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.
Interventions
- Device rTMS Treatment
1 Hz rTMS
Primary outcome measures
- Yale Brown Obsessive Compulsive Scale score [Time frame: baseline and 25 days]
Secondary outcome measures (6)
- Yale Brown Obsessive Compulsive Scale [Time frame: baseline and 70 days]
- general assessement functioning (GAF) [Time frame: baseline and 25 days]
- general assessement functioning (GAF) [Time frame: baseline and 70 days]
- Clinical Global Impression (CGI) [Time frame: baseline and 25 days]
- Clinical Global Impression (CGI) [Time frame: baseline and 70 days]
- Adverse events linked to the rTMS treatment [Time frame: 70 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Sorbonne University, Pitié-Salpêtrière Hospital — Paris
- Centre Hospitalier Henri Laborit — Poitiers
Identifiers
NCT: NCT04934007 · 2017-A02544-49