Obsessive-compulsive Disorders and SymptomstDCS-TOCNCT03284671
tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study
A study testing bifocal stimulation with tDCS in people with Obsessive-compulsive Disorders and Symptoms, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obsessive-compulsive Disorders and Symptoms
- What is being tested?
- bifocal stimulation with tDCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2016to 12 May 2017
- 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 DSM-IV with a "good insight" (BABS),
- Age: Participants will be both males and females, 18-70 years of age included.
- No current depressive and suicidal risks,
- No epileptic pathology,
- Chronic evolution ( Total Y-BOCS>20 ),
- Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year,
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- Stability treatment (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
- Meets another diagnosis of axe 1 of DSM-IV,
- Current depressive or suicidal risks,
- Patient with a benzodiazepine treatment,
- Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) ,
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- Epileptic patient,
- Patient with a medical history of cranial trauma,
- Patient unable to give his or hers informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)
The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.
- Being tested
- bifocal stimulation with tDCS
- Keywords
- Transcranial Direct Current Stimulation, Supplementary motor area, Orbitofrontal cortex
- 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.
bifocal stimulation with tDCSOther
Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)
| Study group | Role | What they receive |
|---|---|---|
| bifocal stimulation | Experimental | Transcranial direct current Bifocal stimulation Receives: Other: bifocal stimulation with tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment
Score improvement on the Y-BOCS after 14 days compared to the baseline
Measured: Day 14
Secondary outcomes (11)
Evaluate the persistence of therapeutic response at 45 days
Score improvement on the Y-BOCS after 45 days compared to the baseline
Measured: Day 45
Evaluate the persistence of therapeutic response at 105 days
Score improvement on the Y-BOCS after 105 days compared to the baseline
Measured: Day 105
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days
Score improvement of Hamilton and HDRS scales between the baseline and day 14
Measured: Day 14
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days
Score improvement of Hamilton and HDRS scales between the baseline and day 45
Measured: Day 45
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days
Score improvement of Hamilton and HDRS scales between the baseline and day 105
Measured: Day 105
Evaluate the effect of tDCS on the quality of life at day 14
Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14
Measured: Day 14
Evaluate the effect of tDCS on the quality of life at day 45
Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45
Measured: Day 45
Evaluate the effect of tDCS on global functioning at day 14
Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14
Measured: Day 14
Evaluate the effect of tDCS on global functioning at day 45
Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45
Measured: Day 45
Evaluate the effect of tDCS on social adjustment at day 14
Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14
Measured: Day 14
Evaluate the effect of tDCS on social adjustement at day 45
Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start19 Feb 2016
- Primary completion19 Feb 2016
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-compulsive Disorders and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nematollah JAAFARI, Professor, Study director, Centre Hospitalier Henri Laborit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284671
- Sponsor's protocol ID
- tDCS-TOC pilote
- Acronym
- tDCS-TOC
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2017
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Harika-Germaneau G, Heit D, Chatard A, Thirioux B, Langbour N, Jaafari N. Treating refractory obsessive-compulsive disorder with transcranial direct current stimulation: An open label study. Brain Behav. 2020 Jul;10(7):e01648. doi: 10.1002/brb3.1648. Epub 2020 May 14.
PubMed 32406608
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)
- ClinicalTrials.gov ID
- NCT03284671
- Acronym / sponsor ID
- tDCS-TOC / tDCS-TOC pilote
- Keywords
- Transcranial Direct Current Stimulation, Supplementary motor area, Orbitofrontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 19 Feb 2016 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bifocal stimulation | Experimental | Other: bifocal stimulation with tDCSTranscranial direct current Bifocal stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meets criteria for obsessive compulsive disorder according to DSM-IV with a "good insight" (BABS),
- Age: Participants will be both males and females, 18-70 years of age included.
- No current depressive and suicidal risks,
- No epileptic pathology,
- Chronic evolution ( Total Y-BOCS>20 ),
Key exclusion criteria (9 listed)
- Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
- Patient under curators
- Meets another diagnosis of axe 1 of DSM-IV,
- Current depressive or suicidal risks,
- Patient with a benzodiazepine treatment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bifocal stimulation with tDCSPatients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA) | Other | bifocal stimulation |
Primary outcome
The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment
Time frame: Day 14
Score improvement on the Y-BOCS after 14 days compared to the baseline
11 secondary outcomes
Evaluate the persistence of therapeutic response at 45 days
Time frame: Day 45
Evaluate the persistence of therapeutic response at 105 days
Time frame: Day 105
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days
Time frame: Day 14
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days
Time frame: Day 45
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days
Time frame: Day 105
Evaluate the effect of tDCS on the quality of life at day 14
Time frame: Day 14
Evaluate the effect of tDCS on the quality of life at day 45
Time frame: Day 45
Evaluate the effect of tDCS on global functioning at day 14
Time frame: Day 14
Evaluate the effect of tDCS on global functioning at day 45
Time frame: Day 45
Evaluate the effect of tDCS on social adjustment at day 14
Time frame: Day 14
Evaluate the effect of tDCS on social adjustement at day 45
Time frame: Day 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Results publication: PubMed 32406608Harika-Germaneau G, Heit D, Chatard A, Thirioux B, Langbour N, Jaafari N. Treating refractory obsessive-compulsive disorder with transcranial direct current stimulation: An open label study. Brain Behav. 2020 Jul;10(7):e01648. doi: 10.1002/brb3.1648. Epub 2020 May 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nematollah JAAFARI, Professor study director
Centre Hospitalier Henri Laborit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bifocal stimulation with tDCS in people with Obsessive-compulsive Disorders and Symptoms, run by Centre Hospitalier Henri Laborit 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 9 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 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. 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?
The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment (time frame: Day 14). 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 NCT03284671, 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.