Status:
RECRUITING
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Lead Sponsor:
Centre Hospitalier Henri Laborit
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
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, a...
Eligibility Criteria
Inclusion
- 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:
- at least 2 antidepressants of the IRS type at an effective dose and for a sufficient duration
- 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
- 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
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06017713
Start Date
October 17 2023
End Date
July 1 2027
Last Update
June 5 2025
Active Locations (1)
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1
Centre Hospitalier Henri Laborit
Poitiers, France