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Obsessive-Compulsive DisordertDCS-TOCNCT03304600

tDCS for Treatment Resistant Obsessive Compulsive Disorder

A study testing Active stimulation in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Henri Laborit at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Active stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
4 sitesFrance
Study dates
3 Nov 2017to 24 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a "good insight" (BABS)
  • No current depressive and suicidal risks
  • No epileptic pathology
  • Age: Participants will be both males and females, 18-70 years of age included.
  • Chronic Obsessive compulsive disorder ( Total Y-BOCS>20 or Y-BOCS one subscale > 15)
  • Obsessive compulsive disorder resistant to pharmacology treatment :
Show all 11Show fewer
  • at least 2 antidepressants (IRS type) (> 12 weeks)
  • cognitive and comportment therapy since at least one year
  • Treatment stability (antidepressants) for more than 12 weeks without significant improvement.
  • Affiliation to a social security system (recipient or assignee),
  • Signed written inform consent form

Who cannot join

  • Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
  • Patient under curators
  • Patient hospitalized under duress
  • Meets another diagnosis of axe 1 of DSM-IV
  • Current depressive or suicidal risks
  • Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash)
Show all 9Show fewer
  • Epileptic patient
  • Patient with a medical history of cranial trauma
  • Patient unable to give his or hers informed consent

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Hospices Civils De Lyon

    Lyon

  • CHU de Nantes

    Nantes, 44093

  • Centre Hospitalier Henri Laborit

    Poitiers, 86021

  • C.H. Guillaume Regnier

    Rennes, 35703

Other trials in France

About this study

Official title: Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder

It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.

Being tested
Active stimulation, Sham stimulation
Keywords
OCD, tDCS
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.

  • Active stimulationDevice

    Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).

  • Sham stimulationDevice

    Patients will receive a Sham stimulation during 30 mn

Study groups in NCT03304600
Study groupRoleWhat they receive
Active stimulationExperimental10 sessions (1 per day during 2 week) of active tDCS stimulation
Receives: Device: Active stimulation
Sham StimulationSham comparator10 sessions (1 per day during 2 week) of sham stimulation
Receives: Device: Sham stimulation

What is being measured

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

  1. Yale Brown Obsessive Compulsive Scale (YBOCS) score

    The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups

    Measured: 2 weeks

Secondary outcomes (14)

  1. Yale Brown Obsessive Compulsive Scale (YBOCS)

    1. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.

    Measured: Month 1

  2. Yale Brown Obsessive Compulsive Scale (YBOCS),

    ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.

    Measured: Month 3

  3. Clinical Global Impression (CGI)

    Change from baseline to month 1 in above scales between treatment groups;

    Measured: Month 1

  4. Clinical Global Impression (CGI)

    Change from baseline to month 3 in above scales between treatment groups;

    Measured: Month 3

  5. Brown Assessment of Beliefs Scale (BABS)

    Change from baseline to month 1 in above scales between treatment groups;

    Measured: Month 1

  6. Brown Assessment of Beliefs Scale (BABS)

    Change from baseline to month 3 in above scales between treatment groups;

    Measured: Month 3

  7. Brief Anxiety Scale (BAS)

    Change from baseline to month 1 in above scales between treatment groups;

    Measured: Month 1

  8. Brief Anxiety Scale (BAS)

    Change from baseline to month 3 in above scales between treatment groups;

    Measured: Month 3

  9. Montgomery and Asberg Depression Rating Scale (MADRS)

    Change from baseline to month 1 in above scales between treatment groups;

    Measured: Month 1

  10. Montgomery and Asberg Depression Rating Scale (MADRS)

    Change from baseline to month 3 in above scales between treatment groups;

    Measured: Month 3

  11. Hospital Anxiety and Depression scale (HAD)

    Change from baseline to month 1 in above scales between treatment groups;

    Measured: Month 1

  12. Hospital Anxiety and Depression scale (HAD)

    Change from baseline to month 3 in above scales between treatment groups;

    Measured: Month 3

  13. Sheehan Disability Scale, (SDS)

    Change from baseline to month 1 in above scales between treatment groups;

    Measured: Month 1

  14. Sheehan Disability Scale, (SDS)

    Change from baseline to month 3 in above scales between treatment groups;

    Measured: Month 3

Timeline

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

  1. First posted9 Oct 2017
  2. Study start3 Nov 2017
  3. Primary completion24 Feb 2022
  4. Study completion24 Feb 2022

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
Double blind
Who is masked
Participant, Investigator
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03304600
Sponsor's protocol ID
2016-A01983-48
Acronym
tDCS-TOC
Status last verified
Sep 2026
First submitted
29 Sep 2017
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Harika-Germaneau G, Heit D, Drapier D, Sauvaget A, Bation R, Chatard A, Doolub D, Wassouf I, Langbour N, Jaafari N. Treating refractory obsessive compulsive disorder with cathodal transcranial direct current stimulation over the supplementary motor area: a large multisite randomized sham-controlled double-blind study. Front Psychiatry. 2024 May 17;15:1338594. doi: 10.3389/fpsyt.2024.1338594. eCollection 2024.

    PubMed 38827437

Questions about this trial

What is this clinical trial studying?

A study testing Active stimulation in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Henri Laborit at 4 sites 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Obsessive Compulsive Scale (YBOCS) score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03304600, which also lists 1 linked publication.

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 9 Sep 2026.

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