Obsessive-Compulsive DisorderPPSTDCS-TOCNCT06017713
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
A study testing tDCS + symptoms provocation in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- tDCS + symptoms provocation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2023to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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. ;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers
Ghina Harika Germaneau
About this study
Official title: Direct Transcranial Stimulation With Direct Current Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive
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.
Read more
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
- Being tested
- tDCS + symptoms provocation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS + symptoms provocationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS + symptoms provocation | Experimental | Not described Receives: Behavioral: tDCS + symptoms provocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start17 Oct 2023
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017713
- Sponsor's protocol ID
- 2023-A01148-37
- Acronym
- PPSTDCS-TOC
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No