Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder (ORBITOC3)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring rTMS, D-B80 A/P
Eligibility Criteria
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
Sites / Locations
- Sorbonne University, Pitié-Salpêtrière HospitalRecruiting
- Centre Hospitalier Henri LaboritRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active stimulation
Sham Stimulation
Arm Description
Active rTMS stimulation , 2 session per day during 10 days.
Sham rTMS stimulation , 2 session per day during 10 days.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Yale Brown Obsessive Compulsive Scale
Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70
general assessement functioning (GAF)
Change of the general assessement functioning (GAF) at day 25
general assessement functioning (GAF)
Change of the general assessement functioning (GAF) at day 70
Clinical Global Impression (CGI)
Clinical Global Impressions (CGI) change at day 25
Clinical Global Impression (CGI)
Clinical Global Impressions (CGI) change at day 70
Adverse events linked to the rTMS treatment
Number and types of adverse events linked to the rTMS treatment
Full Information
NCT ID
NCT04934007
First Posted
June 7, 2021
Last Updated
August 18, 2023
Sponsor
Centre Hospitalier Henri Laborit
1. Study Identification
Unique Protocol Identification Number
NCT04934007
Brief Title
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Acronym
ORBITOC3
Official Title
A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
rTMS, D-B80 A/P
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
Active rTMS stimulation , 2 session per day during 10 days.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
Sham rTMS stimulation , 2 session per day during 10 days.
Intervention Type
Device
Intervention Name(s)
rTMS Treatment
Intervention Description
1 Hz rTMS
Primary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale score
Description
Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25
Time Frame
baseline and 25 days
Secondary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale
Description
Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70
Time Frame
baseline and 70 days
Title
general assessement functioning (GAF)
Description
Change of the general assessement functioning (GAF) at day 25
Time Frame
baseline and 25 days
Title
general assessement functioning (GAF)
Description
Change of the general assessement functioning (GAF) at day 70
Time Frame
baseline and 70 days
Title
Clinical Global Impression (CGI)
Description
Clinical Global Impressions (CGI) change at day 25
Time Frame
baseline and 25 days
Title
Clinical Global Impression (CGI)
Description
Clinical Global Impressions (CGI) change at day 70
Time Frame
baseline and 70 days
Title
Adverse events linked to the rTMS treatment
Description
Number and types of adverse events linked to the rTMS treatment
Time Frame
70 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghina Harika-Germaneau, MD, PhD
Phone
+33 5 16 52 61 18
Email
ghina.harika.germaneau@ch-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nematollah Jaafari, PR
Phone
+33 5 16 52 61 18
Email
nemat.jaafari@ch-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghina Harika-Germaneau
Organizational Affiliation
Centre Hospitalier Henri Laborit
Official's Role
Study Director
Facility Information:
Facility Name
Sorbonne University, Pitié-Salpêtrière Hospital
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Millet, PR
Email
b.millet@aphp.fr
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghina Harika-Germaneau, MD, PhD
Phone
+33 5 16 52 61 18
Email
ghina.harika-germaneau@ch-poitiers.fr
12. IPD Sharing Statement
Learn more about this trial
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
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