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

Sponsor

Centre Hospitalier Henri Laborit (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06017713

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center study about patients with severe resistant OCD.

We hypothesize 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).

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Behavioral: tDCS + symptoms provocation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Direct Transcranial Stimulation With Direct Current Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS + symptoms provocation	Behavioral: tDCS + symptoms provocation 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.

Arm

Intervention/Treatment

Experimental: tDCS + symptoms provocation

Behavioral: tDCS + symptoms provocation

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.

Outcome Measures

Primary Outcome Measures

YBOCS scale [3,5 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Henri Laborit	Poitiers		France

Sponsors and Collaborators

Centre Hospitalier Henri Laborit

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Henri Laborit

ClinicalTrials.gov Identifier:

NCT06017713

Other Study ID Numbers:

2023-A01148-37

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Compulsive Personality Disorder

Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Aug 30, 2023