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NCT Number: NCT06017713

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

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).

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Henri Laborit

Poitiers, France

Location status: Recruiting

Location contact

Ghina Harika Germaneau

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

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.

Primary outcomes

  1. YBOCS scale

    Time frame: 3,5 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghina HARIKA-GERMANEAU, Dr

CONTACT

[email protected]

516526118 ext. 0033

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Registry information

Official study title

Direct Transcranial Stimulation With Direct Current Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive

Acronym: PPSTDCS-TOC

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2023
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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