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Obsessive-Compulsive DisorderEFFI-STOCNCT04106102

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

A study testing Transcramial Direct current stimulation in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Transcramial Direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
1 siteFrance
Study dates
20 Sep 2019to 9 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de Nice

    Nice, 06003

Other trials in France

About this study

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.

Read the detailed description

Obsessive-compulsive disorder (OCD) is a common psychiatric condition (prevalence 2-3%), with a chronic course, and significantly impairs the quality of life and functioning of sufferers quality of life and functioning. Cognitive-behavioral psychotherapies are the standard treatment, and 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 (Pallanti \& Quercioli, 2006).

Recent advances in neuroimaging techniques have enabled us to pinpoint the neuroanatomical basis of OCD. of OCD, notably involving dysfunctions affecting cortico-striato-pallido-thalamocortical circuits.

This knowledge of the pathophysiology of the disease has led to the development of focal intervention strategies, aimed at modulating the activity of these cortico-subcortical loops in order to reduce obsessive-compulsive symptomatology, using invasive (deep brain stimulation via stereotactic electrode implantation) or non-invasive (repeated trancranial magnetic stimulation or rTMS) procedures or rTMS). In the case of rTMS, recent studies have demonstrated the efficacy of a single treatment in patients with resistant OCD. the efficacy of low-frequency stimulation of the pre-supplementary motor area (pre-SMA), a brain area involved in cognitive inhibition processes. However, these methods have limitations invasive nature in the case of deep brain stimulation, and the need for an expensive technical for rTMS.

There is therefore a clear need to develop new therapeutic approaches for OCD, combining efficacy efficacy, safety and patient acceptance.

In this context, transcranial direct current stimulation (tDCS) is an extremely interesting alternative. This non-invasive neuromodulation technique involves applying a low-intensity direct current current (1 to 2 mA) between two electrodes positioned on the scalp. It enables modulate neuronal activity in different brain areas simultaneously. It also has the advantage of being the advantage of simple, low-cost use, as well as excellent tolerance.

TDCS has already provided evidence of its efficacy, as a complement to medication-based approaches, in a variety of clinical contexts, such as depression (Kalu et al., 2012) or acoustic-verbal hallucinations (Brunelin et al., 2012).

With regard to OCD, preliminary data, in the form of case reports (Narayanaswamy \& al., 2015; Mondino \& al., 2015) and open studies (Bation \& al., 2016), appear very promising. In Bation \& al.'s study, in 8 patients with drug-resistant OCD, tDCS led to an average 26.4% reduction in symptoms (measured by the Y-BOCS scale).

There is currently no consensus regarding electrode positioning for the treatment of OCD, but studies suggest (Senço \& al., 2015) that a set-up combining the cathode opposite the pre-supplementary motor area motor area and the anode in an extracephalic position (right deltoid) would modulate the brain regions involved in the pathophysiology of OCD.

We propose to study the efficacy and tolerability of tDCS in the treatment of drug-resistant OCD in a in a randomized, controlled, prospective, double-blind trial. To the best of our knowledge, this is the first trial of this type for tDCS in this condition.

Being tested
Transcramial Direct current stimulation, Placebo
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcramial Direct current stimulationDevice

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

  • PlaceboDevice

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

Study groups in NCT04106102
Study groupRoleWhat they receive
Transcramial Direct current stimulationActive comparatorImplement of Transcramial Direct current stimulation
Receives: Device: Transcramial Direct current stimulation
PlaceboPlacebo comparatorNot described
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study start20 Sep 2019
  3. Primary completion9 Sep 2025
  4. Study completion9 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04106102
Sponsor's protocol ID
16-API-02
Acronym
EFFI-STOC
Status last verified
Nov 2025
First submitted
25 Sep 2019
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcramial Direct current stimulation in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Yale-Brown's obsession-compulsion scale (Y-BOCS) (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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