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

NCT04106102 | Active Not Recruiting

• 1 other identifier: 16-API-02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The usual management of Obsessive Compulsive Disorders is based on cognitive-behavioural psychotherapy, as well as the use of serotonergic antidepressants. Nevertheless, a significant proportion of patients (40% to 60%) are non-responders to these conventional therapies, and remain severely handicapped. transcranial Direct current stimulation (tDCS) has already proven its effectiveness, in addition to drug approaches, in various clinical settings, such as depression or acoustic-verbal hallucinations. This technic appears to be an extremely interesting alternative This is a non-invasive neuromodulation technique (application of a low intensity direct current (1 to 2 mA) between two electrodes positioned on the scalp) that allows the neural activity of different brain areas to be modulated simultaneously. It is a simple and inexpensive technique with excellent tolerance.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Yale-Brown's obsession-compulsion scale (Y-BOCS)

  The evolution (continuous parameter) of this score between the beginning of treatment (Baseline BL) and the visit at 3 month will be calculated. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is a scale for assessing obsessive symptomatology scale for assessing obsessional symptomatology. It is reliable, accurate and sensitive to therapeutic changes. The French version is well validated. It allows comprehensive assessment and repeated measurement of two types of target symptoms target symptoms: obsessions (score from 0 to 20) and compulsions (score from 0 to 20), leading to an overall severity score of 0 to 40. Developed since 1989, it is the reference measure of OCD in therapeutic studies. A score of 16 or more is frequently used to select obsessive-compulsive subjects for controlled controlled studies. This is a hetero-questionnaire administered in the form of a structured interview.

  3 month

Study Arms (2)

Transcramial Direct current stimulation

ACTIVE COMPARATOR

Implement of Transcramial Direct current stimulation

Device: Transcramial Direct current stimulation

Placebo

PLACEBO COMPARATOR

Device: Placebo

Interventions

Transcramial Direct current stimulation DEVICE

Two sessions of 5 stimulations will be made on patient with obsessive-compulsive disorder

Transcramial Direct current stimulation

Placebo DEVICE

Two sessions of 5 stimulations will be made on patient with obsessive-compulsive disorder without direct current. They xwill just wear electrodes.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting an obsessive-compulsive disorder according to the criteria of Diagnostic and Statistical Manual of Mental Disorders 5, evolving for at least two years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Bruno GIORDANA, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: September 20, 2019
• Primary Completion: September 9, 2025
• Study Completion (Estimated): September 9, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (1)