tDCS and Symptom Provocation in Treatment-Resistant OCD

NCT07429500 | Not Yet Recruiting

• 1 other identifier: 2025-A00146-43
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this clinical trial is to learn if symptom provocation before transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD) patients. The main question it aims to answer is: Can symptom-provocation before tDCS improve therapeutic response in OCD patients ? Researchers will compare the clinical outcomes of OCD patients having received, in one arm, tDCS and, in the other arm, patients having received tDCS preceded by symptom provocation to see if therapeutic response and various other clinical variables differ.

Conditions

Obsessive - Compulsive Disorder

Keywords

tDCS

Outcome Measures

Primary Outcomes (1)

• Variation of Yale-Brown Obsessive-Compulsive Scale score

  The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is a clinician-administered assessment used to measure the severity of obsessive-compulsive disorder (OCD). Scores range from 0 to 40, with higher scores indicating more severe symptoms.

  measured at baseline and 42 days after the start of the therapy

Secondary Outcomes (9)

• Persistence of variation of Yale-Brown Obsessive-Compulsive Scale score and Obsessive-Compulsive Inventory-Revised

  measured between baseline, day 102 / day 162

• Comparison of Clinical Global Impression Improvement between both groups

  Scales assessed at baseline, day 42, 102 and 162

• Assessment of the Montgomery and Asberg Depression Rating Scale

  Scales assessed at baseline, day 42, day 102, day 162

• Assessment of 36-Item Short Form Health Survey

  baseline, day 102, and day 162

• Analysis of side effects and tolerance of tDCS

  Assessed during treatment

Study Arms (2)

tDCS

SHAM COMPARATOR

These patients will only receive tDCS

Procedure: tDCS session

tDCS + symptom provocation

ACTIVE COMPARATOR

These patients will experience symptom provocation followed with tDCS

Procedure: tDCS session; Behavioral: symptom provocation

Interventions

tDCS session PROCEDURE

An active bifocal tDCS delivered through a CE-certified stimulator. The bifocal montage consists of an anodal electrode over the right orbitofrontal cortex (OFC) and a cathodal electrode over the supplementary motor area (SMA), with 5X5 cm electrod. Stimulation intensity is set at 2 mA, with a 30-minute session duration, including 30-second ramp-up and ramp-down periods.

tDCS; tDCS + symptom provocation

symptom provocation BEHAVIORAL

A 3-5 minutes personalised symptom provocation procedure immediately before stimulation. This standardised clinical procedure induces brief activation of obsession-related distress without engaging in compulsions. It is delivered by a trained clinician health-care professional and does not constitute psychotherapeutic treatment.

tDCS + symptom provocation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5, with a duration ≥ 2 years.
• Good insight, defined as a BABS score ≤ 18.
• Chronic OCD, with either a Y-BOCS total score \> 20 or a subscale score \> 15.
• Treatment-resistant OCD, defined as:
• failure of ≥ two adequate trials of SSRIs, or
• failure of one SSRI plus augmentation with an atypical antipsychotic,
• and/or insufficient response after ≥ one year of cognitive-behavioural therapy.
• Age 18 to 70 years.
• Ability to provide informed written consent.
• Affiliation with the French social security system.

You may not qualify if:

• Women of childbearing potential without effective contraception, or those unwilling to maintain abstinence or contraception.
• Pregnancy or breastfeeding.
• Compulsory psychiatric hospitalisation.
• Legal guardianship or curatorship.
• Current DSM-5 Axis I disorder other than OCD (schizophrenia spectrum, bipolar disorder, substance use).
• Current major depressive episode (MADRS \> 21).
• Suicide risk (MADRS item 10 \> 3).
• Dermatological lesions at electrode placement sites.
• History of traumatic brain injury.
• Presence of intracranial metal, pacemaker, or epilepsy.
• Emergency situations or inability to provide informed consent.

Sponsors & Collaborators

• Centre Hospitalier Henri Laborit: lead

Study Sites (6)

CH Camille Claudel

Angoulême, 16000, France

Location

CH Esquirol

Limoges, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Unité de Recherche Clinique, Centre Hospitalier Henri Laborit

Poitiers, 86000, France

Location

CH Guillaume Régnier

Rennes, 35000, France

Location

CHNDS

Thouars, 79100, France

Location

MeSH Terms

Conditions

Compulsive Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Ghina Harika-Germaneau, Dr.

CONTACT

+33 5 16 52 61 18; ghina.harika-germaneau@ch-poitiers.fr

Study Design

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

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 15, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FR (6)