NCT06017713 tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
| NCT ID | NCT06017713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Henri Laborit |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-10-17 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2023-10-17 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-center study about patients with severe resistant OCD. Main assumption is that performing 10 tDCS sessions with the anode positioned at the level of the right orbitofrontal cortex, and the cathode at the level of the supplementary motor area, associated with the provocation of symptoms before each session is effective in the reduction in obsessive-compulsive symptoms. After the inclusion visit, the treatment period is provided from D1 to D12 (one session per day from Monday to Friday, for two consecutive weeks, i.e. a total of ten sessions). Each tDCS session lasts 30 minutes at an intensity of 2 mA and is preceded by symptom provocation using a standardized procedure performed by trained personnel. The patients are then assessed on D42 and D102 (i.e. 1 month and 3 months after the end of the tDCS sessions).
Eligibility Criteria
Inclusion Criteria: * Patient suffering from OCD evolving for at least 2 years diagnosed according to DSM-V criteria; * Patient with good insight, defined by a score less than or equal to 18 at the threshold of delusions on the BABS (Brown Assessment of Beliefs Scale) insight scale; * Absence of a current depressive episode (MADRS score \< 21) or suicidal risk (MADRS score item 10 \< 3); * Absence of epileptic pathology; * Chronic obsessive-compulsive disorder defined by a total YBOCS score \> 20, or a subscale score \> 15; * Drug-resistant obsessive-compulsive disorder despite treatment with: 1. at least 2 antidepressants of the IRS type at an effective dose and for a sufficient duration 2. and/or Behavioral and Cognitive therapy for at least 1 year; * Therapeutic stability (antidepressants) for more than 12 weeks without significant improvement. This treatment, at a fixed dose, will be maintained during the study; * Patient aged between 18 and 70 included * Patient who has given his/her informed consent after having received written information on the planned procedure; * Patient benefiting from social security or by benefiting through a third party. Exclusion Criteria: * Woman of childbearing age without effective means of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) * Pregnant or nursing woman; * Patient hospitalized under duress (SPDT, SPDRE); * Patient under guardianship or curatorship; * Patient with another DSM-V Axis 1 diagnosis (Schizophrenic Disorder, Bipolar Disorder, Substance Abuse or Substance Dependence). Generalized anxiety disorder, social phobia, nicotine addiction and history of major depressive episodes are not exclusion criteria. Axis I comorbidity will be explored using MINI 5.0.0. ; * Patient suffering from a current depressive episode; * Patient at risk of suicide; * Patient with skin lesions on the scalp; * History of head trauma; * Patient with an intracerebral metal object * Patient with a pacemaker; * Presence of epileptic pathology; * Patient in an emergency situation or unable to give personal consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06017713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06017713 currently recruiting?
Yes, NCT06017713 is actively recruiting participants. Contact the research team at ghina.harika-germaneau@ch-poitiers.fr for enrollment information.
Where is the NCT06017713 trial being conducted?
This trial is being conducted at Poitiers, France.
Who is sponsoring the NCT06017713 clinical trial?
NCT06017713 is sponsored by Centre Hospitalier Henri Laborit. The trial plans to enroll 25 participants.