Health TrialsbyHealthPanel

tDCS and Symptom Provocation in Treatment-Resistant OCD

ConditionObsessive - Compulsive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Hospitalier Henri Laborit

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

failure of ≥ two adequate trials of SSRIs, or

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • tDCS session

    Procedure/Surgery

    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.

  • 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.

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: tDCSSham comparator 1 intervention
Group B: tDCS + symptom provocationActive comparator 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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

Assessment of the persistence of the therapeutic response at day 102 and 162 with the Y-BOCS and OCI-R scales. The Obsessive-Compulsive Inventory-Revised (OCI-R) is a self-report measure designed to assess the severity and type of obsessive-compulsive disorder (OCD) symptoms. It evaluates six symptom dimensions: washing, checking, ordering, hoarding, neutralizing, and obsessing. Each dimension is scored from 0 to 12, with higher scores indicating greater symptom severity.

Time frame
measured between baseline, day 102 / day 162
2

Comparison of Clinical Global Impression Improvement between both groups

The Clinical Global Impression (CGI) is a hetero-evaluation scale widely used in clinical studies to evaluate baseline severity and improvement in relation to treatment.

Time frame
Scales assessed at baseline, day 42, 102 and 162
3

Assessment of the Montgomery and Asberg Depression Rating Scale

The Montgomery and Asberg Depression Rating Scale (MADRS) is a hetero-evaluation rating scale used to assess the severity of depressive symptoms. It consists of 10 items evaluating core dimensions of depression. Total scores range from 0 to 60, with higher scores indicating more severe depression.

Time frame
Scales assessed at baseline, day 42, day 102, day 162
4

Assessment of 36-Item Short Form Health Survey

The 36-Item Short Form Health Survey (SF-36) is a self-assessed scale to measure 8 dimensions of health and quality of life. Each dimension is graded on a score of 0 to 100, 0 being the poorest estimate of quality of life and 100 being the best.

Time frame
baseline, day 102, and day 162

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Henri Laborit

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: