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tDCS for Treatment Resistant Obsessive Compulsive Disorder (tDCS-TOC)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active stimulation
Sham stimulation
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 focused on measuring OCD, tDCS

Eligibility Criteria

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

Inclusion Criteria:

  • Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a "good insight" (BABS)
  • No current depressive and suicidal risks
  • No epileptic pathology
  • Age: Participants will be both males and females, 18-70 years of age included.
  • Chronic Obsessive compulsive disorder ( Total Y-BOCS>20 or Y-BOCS one subscale > 15)

  • Obsessive compulsive disorder resistant to pharmacology treatment :

    1. at least 2 antidepressants (IRS type) (> 12 weeks)
    2. cognitive and comportment therapy since at least one year
  • Treatment stability (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
  • Patient hospitalized under duress
  • Meets another diagnosis of axe 1 of DSM-IV
  • Current depressive or suicidal risks
  • 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

  • Hospices Civils De Lyon
  • CHU de Nantes
  • Centre Hospitalier Henri Laborit
  • C.H. Guillaume Regnier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active stimulation

Sham Stimulation

Arm Description

10 sessions (1 per day during 2 week) of active tDCS stimulation

10 sessions (1 per day during 2 week) of sham stimulation

Outcomes

Primary Outcome Measures

Yale Brown Obsessive Compulsive Scale (YBOCS) score
The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups

Secondary Outcome Measures

Yale Brown Obsessive Compulsive Scale (YBOCS)
i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.
Yale Brown Obsessive Compulsive Scale (YBOCS),
ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.
Clinical Global Impression (CGI)
Change from baseline to month 1 in above scales between treatment groups;
Clinical Global Impression (CGI)
Change from baseline to month 3 in above scales between treatment groups;
Brown Assessment of Beliefs Scale (BABS)
Change from baseline to month 1 in above scales between treatment groups;
Brown Assessment of Beliefs Scale (BABS)
Change from baseline to month 3 in above scales between treatment groups;
Brief Anxiety Scale (BAS)
Change from baseline to month 1 in above scales between treatment groups;
Brief Anxiety Scale (BAS)
Change from baseline to month 3 in above scales between treatment groups;
Montgomery and Asberg Depression Rating Scale (MADRS)
Change from baseline to month 1 in above scales between treatment groups;
Montgomery and Asberg Depression Rating Scale (MADRS)
Change from baseline to month 3 in above scales between treatment groups;
Hospital Anxiety and Depression scale (HAD)
Change from baseline to month 1 in above scales between treatment groups;
Hospital Anxiety and Depression scale (HAD)
Change from baseline to month 3 in above scales between treatment groups;
Sheehan Disability Scale, (SDS)
Change from baseline to month 1 in above scales between treatment groups;
Sheehan Disability Scale, (SDS)
Change from baseline to month 3 in above scales between treatment groups;

Full Information

First Posted
September 29, 2017
Last Updated
April 21, 2022
Sponsor
Centre Hospitalier Henri Laborit
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03304600
Brief Title
tDCS for Treatment Resistant Obsessive Compulsive Disorder
Acronym
tDCS-TOC
Official Title
Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit
Collaborators
Ministry of Health, France

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
It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
10 sessions (1 per day during 2 week) of active tDCS stimulation
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
10 sessions (1 per day during 2 week) of sham stimulation
Intervention Type
Device
Intervention Name(s)
Active stimulation
Intervention Description
Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
Patients will receive a Sham stimulation during 30 mn
Primary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale (YBOCS) score
Description
The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale (YBOCS)
Description
i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.
Time Frame
Month 1
Title
Yale Brown Obsessive Compulsive Scale (YBOCS),
Description
ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.
Time Frame
Month 3
Title
Clinical Global Impression (CGI)
Description
Change from baseline to month 1 in above scales between treatment groups;
Time Frame
Month 1
Title
Clinical Global Impression (CGI)
Description
Change from baseline to month 3 in above scales between treatment groups;
Time Frame
Month 3
Title
Brown Assessment of Beliefs Scale (BABS)
Description
Change from baseline to month 1 in above scales between treatment groups;
Time Frame
Month 1
Title
Brown Assessment of Beliefs Scale (BABS)
Description
Change from baseline to month 3 in above scales between treatment groups;
Time Frame
Month 3
Title
Brief Anxiety Scale (BAS)
Description
Change from baseline to month 1 in above scales between treatment groups;
Time Frame
Month 1
Title
Brief Anxiety Scale (BAS)
Description
Change from baseline to month 3 in above scales between treatment groups;
Time Frame
Month 3
Title
Montgomery and Asberg Depression Rating Scale (MADRS)
Description
Change from baseline to month 1 in above scales between treatment groups;
Time Frame
Month 1
Title
Montgomery and Asberg Depression Rating Scale (MADRS)
Description
Change from baseline to month 3 in above scales between treatment groups;
Time Frame
Month 3
Title
Hospital Anxiety and Depression scale (HAD)
Description
Change from baseline to month 1 in above scales between treatment groups;
Time Frame
Month 1
Title
Hospital Anxiety and Depression scale (HAD)
Description
Change from baseline to month 3 in above scales between treatment groups;
Time Frame
Month 3
Title
Sheehan Disability Scale, (SDS)
Description
Change from baseline to month 1 in above scales between treatment groups;
Time Frame
Month 1
Title
Sheehan Disability Scale, (SDS)
Description
Change from baseline to month 3 in above scales between treatment groups;
Time Frame
Month 3
Other Pre-specified Outcome Measures:
Title
Number of adverse events
Description
Safety of the tDCS treatment : assessed by physical examination during each tDCS session any other adverse events (AEs)
Time Frame
3 Month

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: Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a "good insight" (BABS) No current depressive and suicidal risks No epileptic pathology Age: Participants will be both males and females, 18-70 years of age included. Chronic Obsessive compulsive disorder ( Total Y-BOCS>20 or Y-BOCS one subscale > 15) Obsessive compulsive disorder resistant to pharmacology treatment : at least 2 antidepressants (IRS type) (> 12 weeks) cognitive and comportment therapy since at least one year Treatment stability (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 Patient hospitalized under duress Meets another diagnosis of axe 1 of DSM-IV Current depressive or suicidal risks 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
Damien HEIT, MD
Organizational Affiliation
Centre Hospitalier Henri Laborit
Official's Role
Study Director
Facility Information:
Facility Name
Hospices Civils De Lyon
City
Lyon
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
C.H. Guillaume Regnier
City
Rennes
ZIP/Postal Code
35703
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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tDCS for Treatment Resistant Obsessive Compulsive Disorder

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