Using tDCS with symptom provocation to treat resistant OCD

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

This study is testing if a new treatment using brain stimulation along with triggering OCD symptoms can help people with severe OCD who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Centre Hospitalier Henri Laborit (Academic / other)
• Locations: 1 site (Poitiers)
• Trial ID: NCT06017713 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of transcranial direct current stimulation (tDCS) combined with symptom provocation in patients with severe, treatment-resistant obsessive-compulsive disorder (OCD). Participants will undergo ten tDCS sessions over two weeks, with each session lasting 30 minutes and preceded by a standardized symptom provocation procedure. The primary goal is to assess the reduction in obsessive-compulsive symptoms following the treatment, with evaluations conducted one and three months post-treatment. The study is conducted at a single center, ensuring a controlled environment for the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with chronic, treatment-resistant OCD diagnosed for at least two years.

Not a fit: Patients with current depressive episodes, suicidal risk, or those with a history of epilepsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new therapeutic option for patients suffering from resistant OCD.

How similar studies have performed: While the combination of tDCS and symptom provocation is a novel approach, previous studies have shown promise in using tDCS for OCD treatment.

Eligibility criteria

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:

  1. at least 2 antidepressants of the IRS type at an effective dose and for a sufficient duration
  2. 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

Where this trial is running

Poitiers

• Centre Hospitalier Henri Laborit — Poitiers, France (Recruiting)

Study contacts

• Study coordinator: Ghina HARIKA-GERMANEAU, Dr

Conditions Obsessive-Compulsive Disorder