Effect of Transcranial Direct Current Stimulation on Obsessive Compulsive Disorder

Study of the Effectiveness of Transcranial Direct Current Stimulation on Obsessive Compulsive Disorder

This study is testing if a new brain stimulation treatment can help people with obsessive-compulsive disorder who haven't found relief from regular therapies.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (other)
• Locations: 1 site (Nice)
• Trial ID: NCT04106102 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of transcranial direct current stimulation (tDCS) as a treatment for patients with obsessive-compulsive disorder (OCD) who have not responded to conventional therapies. tDCS is a non-invasive neuromodulation technique that applies a low-intensity direct current to modulate neural activity in specific brain areas. The study aims to assess the impact of tDCS on reducing OCD symptoms in patients who have been resistant to standard treatments, including serotonergic antidepressants and cognitive-behavioral therapy. Participants will be compared to a placebo group to evaluate the efficacy of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with OCD for at least two years, who have not responded to two different serotonergic antidepressants and cognitive-behavioral therapy.

Not a fit: Patients with psychotic disorders, bipolar mood disorder, or those at risk of suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with OCD who do not respond to existing therapies.

How similar studies have performed: Previous studies have shown promising results for tDCS in treating various psychiatric conditions, suggesting potential for success in this novel application for OCD.

Eligibility criteria

Inclusion Criteria:

* Presenting an obsessive-compulsive disorder according to the criteria of Diagnostic and Statistical Manual of Mental Disorders 5, evolving for at least two years
* Of significant clinical intensity: Yale-Brown's obsession-compulsion scale ≥ 16/40 continuously over the last 6 months. This criteria of persistent severity over the last 6 months will be explored by an in-depth clinical interview at the inclusion visit (Baseline BL)
* Resistant despite treatment with: 2 serotonergic antidepressants, each received for at least 8 weeks, at the maximum recommended or tolerated dosage AND behavioural and cognitive therapy for at least 6 months
* Drug treatment unchanged for at least 12 weeks

Exclusion Criteria:

* Patient with psychotic disorder, bipolar mood disorder, substance abuse or dependence (excluding tobacco)
* Patient at risk of suicide (score ≥ 2 on item 10 of the Montgomery-Åsberg depression rating scale)
* Contraindications to the practice of transcranial direct stimulation : history of cerebral pathology, intracranial hypertension, neurosurgery, cephalic metal implant, pacemaker
* Unbalanced epilepsy
* Previous use of transcranial direct stimulation (problem of maintaining the integrity of the blind procedure)
* Pregnancy or breastfeeding in progress, woman in a state of procreation without effective contraception (a urine pregnancy test will be performed)
* Scalp skin pathology

Where this trial is running

Nice

• CHU de Nice — Nice, France (RECRUITING)

Study contacts

• Principal investigator: Bruno GIORDANA, MD — Centre Hospitalier Universitaire de Nice
• Study coordinator: Bruno GIORDANA, MD

Conditions: Obsessive-Compulsive Disorder