Obsessive-Compulsive DisorderORBITOC3NCT04934007
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
A study testing rTMS Treatment in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Henri Laborit at 2 sites in France.
Trial summary
According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- rTMS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Sep 2021to Sep 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Participants will be both males and females, 18-65 years of age included.
- diagnosis of OCD
- all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks
- Affiliation to a social security system (recipient or assignee),
- Signed written inform consent form
Who cannot join
- The exclusion criteria are a diagnosis of another psychiatric disorder (except for anxious disorders), a diagnosis of a significant active medical illness, pregnancy or other neurological illness
- In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded
- The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day 0.
- 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
- Patient unable to give his or hers informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Sorbonne University, Pitié-Salpêtrière Hospital
Paris
Bruno Millet, PR, b.millet@aphp.fr
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers, 86021
Ghina Harika-Germaneau, MD, PhD, +33 5 16 52 61 18, ghina.harika-germaneau@ch-poitiers.fr
About this study
Official title: A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- rTMS Treatment
- Keywords
- rTMS, D-B80 A/P
- 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.
rTMS TreatmentDevice
1 Hz rTMS
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Active rTMS stimulation , 2 session per day during 10 days. Receives: Device: rTMS Treatment |
| Sham Stimulation | Sham comparator | Sham rTMS stimulation , 2 session per day during 10 days. Receives: Device: rTMS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale score
Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25
Measured: baseline and 25 days
Secondary outcomes (6)
Yale Brown Obsessive Compulsive Scale
Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70
Measured: baseline and 70 days
general assessement functioning (GAF)
Change of the general assessement functioning (GAF) at day 25
Measured: baseline and 25 days
general assessement functioning (GAF)
Change of the general assessement functioning (GAF) at day 70
Measured: baseline and 70 days
Clinical Global Impression (CGI)
Clinical Global Impressions (CGI) change at day 25
Measured: baseline and 25 days
Clinical Global Impression (CGI)
Clinical Global Impressions (CGI) change at day 70
Measured: baseline and 70 days
Adverse events linked to the rTMS treatment
Number and types of adverse events linked to the rTMS treatment
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start6 Sep 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghina Harika-Germaneau, Study director, Centre Hospitalier Henri Laborit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934007
- Sponsor's protocol ID
- 2017-A02544-49
- Acronym
- ORBITOC3
- Status last verified
- Jan 2026
- First submitted
- 7 Jun 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT04934007
- Acronym / sponsor ID
- ORBITOC3 / 2017-A02544-49
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- rTMS, D-B80 A/P
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Jun 2021 (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.
According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: rTMS TreatmentActive rTMS stimulation , 2 session per day during 10 days. |
| Sham Stimulation | Sham comparator | Device: rTMS TreatmentSham rTMS stimulation , 2 session per day during 10 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: Participants will be both males and females, 18-65 years of age included.
- diagnosis of OCD
- all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks
- Affiliation to a social security system (recipient or assignee),
- Signed written inform consent form
Key exclusion criteria (7 listed)
- The exclusion criteria are a diagnosis of another psychiatric disorder (except for anxious disorders), a diagnosis of a significant active medical illness, pregnancy or other neurological illness
- In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded
- The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day 0.
- Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
- Patient under curators
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 |
|---|---|---|
| rTMS Treatment1 Hz rTMS | Device | Active stimulation, Sham Stimulation |
Primary outcome
Yale Brown Obsessive Compulsive Scale score
Time frame: baseline and 25 days
Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25
6 secondary outcomes
Yale Brown Obsessive Compulsive Scale
Time frame: baseline and 70 days
general assessement functioning (GAF)
Time frame: baseline and 25 days
general assessement functioning (GAF)
Time frame: baseline and 70 days
Clinical Global Impression (CGI)
Time frame: baseline and 25 days
Clinical Global Impression (CGI)
Time frame: baseline and 70 days
Adverse events linked to the rTMS treatment
Time frame: 70 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
Ghina Harika-Germaneau study director
Centre Hospitalier Henri Laborit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS Treatment in people with Obsessive-Compulsive Disorder, run by Centre Hospitalier Henri Laborit at 2 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 5 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Contact Ghina Harika-Germaneau, MD, PhD (+33 5 16 52 61 18, ghina.harika.germaneau@ch-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale score (time frame: baseline and 25 days). 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 13 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.