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NCT Number: NCT04934007

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorbonne University, Pitié-Salpêtrière Hospital, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

rTMS treatment

Device

1 Hz rTMS

Primary outcomes

  1. 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

Secondary outcomes

  1. Yale Brown Obsessive Compulsive Scale

    Time frame: baseline and 70 days

    Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70

  2. general assessement functioning (GAF)

    Time frame: baseline and 25 days

    Change of the general assessement functioning (GAF) at day 25

  3. general assessement functioning (GAF)

    Time frame: baseline and 70 days

    Change of the general assessement functioning (GAF) at day 70

  4. Clinical Global Impression (CGI)

    Time frame: baseline and 25 days

    Clinical Global Impressions (CGI) change at day 25

  5. Clinical Global Impression (CGI)

    Time frame: baseline and 70 days

    Clinical Global Impressions (CGI) change at day 70

  6. Adverse events linked to the rTMS treatment

    Time frame: 70 days

    Number and types of adverse events linked to the rTMS treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Ghina Harika-Germaneau, MD, PhD

CONTACT

[email protected]

+33 5 16 52 61 18

Nematollah Jaafari, PR

CONTACT

[email protected]

+33 5 16 52 61 18

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Registry information

Official study title

A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

Acronym: ORBITOC3

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2021
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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