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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Hospitalier Henri Laborit

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: tDCS + symptoms provocationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
3,5 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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