tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder

NCT06017713 | Recruiting

• 1 other identifier: 2023-A01148-37
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• YBOCS scale

  The primary endpoint corresponds to the change in the score on the YBOCS scale between the inclusion visit (Day 0) and the Day 42 visit. A score of 0 corresponds to the absence of OCD and a score of 40 to maximum severity.

  3,5 months

Study Arms (1)

tDCS + symptoms provocation

EXPERIMENTAL

Behavioral: tDCS + symptoms provocation

Interventions

tDCS + symptoms provocation BEHAVIORAL

The treatment consists of 10 sessions of tDCS. Each tDCS session lasts 30 minutes at an intensity of 2mA and is preceded by a provocation of symptoms.

tDCS + symptoms provocation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Centre Hospitalier Henri Laborit: lead

Study Sites (1)

Centre Hospitalier Henri Laborit

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Ghina HARIKA-GERMANEAU, Dr

CONTACT

516526118; ghina.harika-germaneau@ch-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (1)