search
Back to results

tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder (PPSTDCS-TOC)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tDCS + symptoms provocation
Sponsored by
Centre Hospitalier Henri Laborit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient suffering from OCD evolving for at least 2 years diagnosed according to DSM-V criteria; Patient with good insight, defined by a score less than or equal to 18 at the threshold of delusions on the BABS (Brown Assessment of Beliefs Scale) insight scale; Absence of a current depressive episode (MADRS score < 21) or suicidal risk (MADRS score item 10 < 3); Absence of epileptic pathology; Chronic obsessive-compulsive disorder defined by a total YBOCS score > 20, or a subscale score > 15; Drug-resistant obsessive-compulsive disorder despite treatment with: at least 2 antidepressants of the IRS type at an effective dose and for a sufficient duration and/or Behavioral and Cognitive therapy for at least 1 year; Therapeutic stability (antidepressants) for more than 12 weeks without significant improvement. This treatment, at a fixed dose, will be maintained during the study; Patient aged between 18 and 70 included Patient who has given his/her informed consent after having received written information on the planned procedure; Patient benefiting from social security or by benefiting through a third party. Exclusion Criteria: Woman of childbearing age without effective means of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) Pregnant or nursing woman; Patient hospitalized under duress (SPDT, SPDRE); Patient under guardianship or curatorship; Patient with another DSM-V Axis 1 diagnosis (Schizophrenic Disorder, Bipolar Disorder, Substance Abuse or Substance Dependence). Generalized anxiety disorder, social phobia, nicotine addiction and history of major depressive episodes are not exclusion criteria. Axis I comorbidity will be explored using MINI 5.0.0. ; Patient suffering from a current depressive episode; Patient at risk of suicide; Patient with skin lesions on the scalp; History of head trauma; Patient with an intracerebral metal object Patient with a pacemaker; Presence of epileptic pathology; Patient in an emergency situation or unable to give personal consent

Sites / Locations

  • Centre Hospitalier Henri Laborit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS + symptoms provocation

Arm Description

Outcomes

Primary Outcome Measures

YBOCS scale
The primary endpoint corresponds to the change in the score on the YBOCS scale between the inclusion visit (Day 0) and the Day 42 visit. A score of 0 corresponds to the absence of OCD and a score of 40 to maximum severity.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2023
Last Updated
October 17, 2023
Sponsor
Centre Hospitalier Henri Laborit
search

1. Study Identification

Unique Protocol Identification Number
NCT06017713
Brief Title
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Acronym
PPSTDCS-TOC
Official Title
Direct Transcranial Stimulation With Direct Current Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-center study about patients with severe resistant OCD. Main assumption is that performing 10 tDCS sessions with the anode positioned at the level of the right orbitofrontal cortex, and the cathode at the level of the supplementary motor area, associated with the provocation of symptoms before each session is effective in the reduction in obsessive-compulsive symptoms. After the inclusion visit, the treatment period is provided from D1 to D12 (one session per day from Monday to Friday, for two consecutive weeks, i.e. a total of ten sessions). Each tDCS session lasts 30 minutes at an intensity of 2 mA and is preceded by symptom provocation using a standardized procedure performed by trained personnel. The patients are then assessed on D42 and D102 (i.e. 1 month and 3 months after the end of the tDCS sessions).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS + symptoms provocation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
tDCS + symptoms provocation
Intervention Description
The treatment consists of 10 sessions of tDCS. Each tDCS session lasts 30 minutes at an intensity of 2mA and is preceded by a provocation of symptoms.
Primary Outcome Measure Information:
Title
YBOCS scale
Description
The primary endpoint corresponds to the change in the score on the YBOCS scale between the inclusion visit (Day 0) and the Day 42 visit. A score of 0 corresponds to the absence of OCD and a score of 40 to maximum severity.
Time Frame
3,5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient suffering from OCD evolving for at least 2 years diagnosed according to DSM-V criteria; Patient with good insight, defined by a score less than or equal to 18 at the threshold of delusions on the BABS (Brown Assessment of Beliefs Scale) insight scale; Absence of a current depressive episode (MADRS score < 21) or suicidal risk (MADRS score item 10 < 3); Absence of epileptic pathology; Chronic obsessive-compulsive disorder defined by a total YBOCS score > 20, or a subscale score > 15; Drug-resistant obsessive-compulsive disorder despite treatment with: at least 2 antidepressants of the IRS type at an effective dose and for a sufficient duration and/or Behavioral and Cognitive therapy for at least 1 year; Therapeutic stability (antidepressants) for more than 12 weeks without significant improvement. This treatment, at a fixed dose, will be maintained during the study; Patient aged between 18 and 70 included Patient who has given his/her informed consent after having received written information on the planned procedure; Patient benefiting from social security or by benefiting through a third party. Exclusion Criteria: Woman of childbearing age without effective means of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) Pregnant or nursing woman; Patient hospitalized under duress (SPDT, SPDRE); Patient under guardianship or curatorship; Patient with another DSM-V Axis 1 diagnosis (Schizophrenic Disorder, Bipolar Disorder, Substance Abuse or Substance Dependence). Generalized anxiety disorder, social phobia, nicotine addiction and history of major depressive episodes are not exclusion criteria. Axis I comorbidity will be explored using MINI 5.0.0. ; Patient suffering from a current depressive episode; Patient at risk of suicide; Patient with skin lesions on the scalp; History of head trauma; Patient with an intracerebral metal object Patient with a pacemaker; Presence of epileptic pathology; Patient in an emergency situation or unable to give personal consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghina HARIKA-GERMANEAU, Dr
Phone
516526118
Ext
0033
Email
ghina.harika-germaneau@ch-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghina Harika Germaneau

12. IPD Sharing Statement

Learn more about this trial

tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder

We'll reach out to this number within 24 hrs