search
Back to results

tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study (tDCS-TOC)

Primary Purpose

Obsessive-compulsive Disorders and Symptoms

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bifocal stimulation with tDCS
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 Disorders and Symptoms focused on measuring Transcranial Direct Current Stimulation, Supplementary motor area, Orbitofrontal cortex

Eligibility Criteria

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

Patients must present all of the following criteria in order to be eligible:

Inclusion Criteria:

  • Meets criteria for obsessive compulsive disorder according to DSM-IV with a "good insight" (BABS),
  • Age: Participants will be both males and females, 18-70 years of age included.
  • No current depressive and suicidal risks,
  • No epileptic pathology,
  • Chronic evolution ( Total Y-BOCS>20 ),
  • Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year,
  • Stability treatment (antidepressants) for more than 12 weeks without significant improvement,
  • Affiliation to a social security system (recipient or assignee),
  • Signed written inform consent form.

Exclusion Criteria:

  • Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing,
  • Patient under curators
  • Meets another diagnosis of axe 1 of DSM-IV,
  • Current depressive or suicidal risks,
  • Patient with a benzodiazepine treatment,
  • Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) ,
  • Epileptic patient,
  • Patient with a medical history of cranial trauma,
  • Patient unable to give his or hers informed consent.

Sites / Locations

  • Centre Hospitalier Henri Laborit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bifocal stimulation

Arm Description

Transcranial direct current Bifocal stimulation

Outcomes

Primary Outcome Measures

The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment
Score improvement on the Y-BOCS after 14 days compared to the baseline

Secondary Outcome Measures

Evaluate the persistence of therapeutic response at 45 days
Score improvement on the Y-BOCS after 45 days compared to the baseline
Evaluate the persistence of therapeutic response at 105 days
Score improvement on the Y-BOCS after 105 days compared to the baseline
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days
Score improvement of Hamilton and HDRS scales between the baseline and day 14
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days
Score improvement of Hamilton and HDRS scales between the baseline and day 45
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days
Score improvement of Hamilton and HDRS scales between the baseline and day 105
Evaluate the effect of tDCS on the quality of life at day 14
Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14
Evaluate the effect of tDCS on the quality of life at day 45
Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45
Evaluate the effect of tDCS on global functioning at day 14
Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14
Evaluate the effect of tDCS on global functioning at day 45
Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45
Evaluate the effect of tDCS on social adjustment at day 14
Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14
Evaluate the effect of tDCS on social adjustement at day 45
Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45

Full Information

First Posted
September 7, 2017
Last Updated
September 12, 2017
Sponsor
Centre Hospitalier Henri Laborit
search

1. Study Identification

Unique Protocol Identification Number
NCT03284671
Brief Title
tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study
Acronym
tDCS-TOC
Official Title
Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
February 19, 2016 (Actual)
Study Completion Date
May 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorders and Symptoms
Keywords
Transcranial Direct Current Stimulation, Supplementary motor area, Orbitofrontal cortex

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
bifocal stimulation
Arm Type
Experimental
Arm Description
Transcranial direct current Bifocal stimulation
Intervention Type
Other
Intervention Name(s)
bifocal stimulation with tDCS
Intervention Description
Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)
Primary Outcome Measure Information:
Title
The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment
Description
Score improvement on the Y-BOCS after 14 days compared to the baseline
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Evaluate the persistence of therapeutic response at 45 days
Description
Score improvement on the Y-BOCS after 45 days compared to the baseline
Time Frame
Day 45
Title
Evaluate the persistence of therapeutic response at 105 days
Description
Score improvement on the Y-BOCS after 105 days compared to the baseline
Time Frame
Day 105
Title
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days
Description
Score improvement of Hamilton and HDRS scales between the baseline and day 14
Time Frame
Day 14
Title
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days
Description
Score improvement of Hamilton and HDRS scales between the baseline and day 45
Time Frame
Day 45
Title
Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days
Description
Score improvement of Hamilton and HDRS scales between the baseline and day 105
Time Frame
Day 105
Title
Evaluate the effect of tDCS on the quality of life at day 14
Description
Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14
Time Frame
Day 14
Title
Evaluate the effect of tDCS on the quality of life at day 45
Description
Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45
Time Frame
Day 45
Title
Evaluate the effect of tDCS on global functioning at day 14
Description
Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14
Time Frame
Day 14
Title
Evaluate the effect of tDCS on global functioning at day 45
Description
Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45
Time Frame
Day 45
Title
Evaluate the effect of tDCS on social adjustment at day 14
Description
Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14
Time Frame
Day 14
Title
Evaluate the effect of tDCS on social adjustement at day 45
Description
Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45
Time Frame
Day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must present all of the following criteria in order to be eligible: Inclusion Criteria: Meets criteria for obsessive compulsive disorder according to DSM-IV with a "good insight" (BABS), Age: Participants will be both males and females, 18-70 years of age included. No current depressive and suicidal risks, No epileptic pathology, Chronic evolution ( Total Y-BOCS>20 ), Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year, Stability treatment (antidepressants) for more than 12 weeks without significant improvement, Affiliation to a social security system (recipient or assignee), Signed written inform consent form. Exclusion Criteria: Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing, Patient under curators Meets another diagnosis of axe 1 of DSM-IV, Current depressive or suicidal risks, Patient with a benzodiazepine treatment, Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) , Epileptic patient, Patient with a medical history of cranial trauma, Patient unable to give his or hers informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nematollah JAAFARI, Professor
Organizational Affiliation
Centre Hospitalier Henri Laborit
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study

We'll reach out to this number within 24 hrs