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

Obsessive-Compulsive Disorder Clinical Trial

— PPSTDCS-TOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017713
• Other study ID #: 2023-A01148-37
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Henri Laborit
• Contact: Ghina HARIKA-GERMANEAU, Dr
• Phone: 516526118
• Email: ghina.harika-germaneau[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

1. at least 2 antidepressants of the IRS type at an effective dose and for a sufficient duration

2. 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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3,5 months