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tDCS as an add-on Treatment in SSRI-resistant OCD (TDCSTOC)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial dirrect current stimulation
Sham tDCS
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD

Eligibility Criteria

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

Inclusion Criteria:

  • patients diagnosed with OCD according to DSM V criteria
  • YBOCS score of 16 and above, stable (<20% of variation) during at least one month.
  • have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
  • age between 18 and 70
  • voluntary and competent to consent

Exclusion Criteria:

  • Major depressive disorder diagnosed with the DSM V criteria with a MADRS score >30 (actual)
  • schizophrenia and other psychotic disorder
  • drugs or alcohol abuse
  • acutely suicidal
  • significant head injury, or of any neurosurgical procedure with implanted material
  • pregnant women

Sites / Locations

  • Centre Hospitalier Le VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active tDCS

SHAM tDCS

Arm Description

patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline

The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds.

Outcomes

Primary Outcome Measures

score improvement on the Yale Brown Obsessive and Compulsive Scale after one month
% of improvement compare to baseline

Secondary Outcome Measures

Number of responders on the YBOCS
Number of responders (decrease >35%) on the Yale Brown Obsessive and Compulsive Scale) or a score of 2 or less on the CGI-I (much or very much improved)
score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months
% of improvement compare to baseline

Full Information

First Posted
March 30, 2015
Last Updated
May 4, 2017
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT02407288
Brief Title
tDCS as an add-on Treatment in SSRI-resistant OCD
Acronym
TDCSTOC
Official Title
Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2015 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder
Detailed Description
Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm) Statistical analysis to address the primary and secondary objectives: Chi squared test will be applied for quantitative data.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline
Arm Title
SHAM tDCS
Arm Type
Placebo Comparator
Arm Description
The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds.
Intervention Type
Device
Intervention Name(s)
transcranial dirrect current stimulation
Other Intervention Name(s)
tdcs
Intervention Description
The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Primary Outcome Measure Information:
Title
score improvement on the Yale Brown Obsessive and Compulsive Scale after one month
Description
% of improvement compare to baseline
Time Frame
1 month after treatment
Secondary Outcome Measure Information:
Title
Number of responders on the YBOCS
Description
Number of responders (decrease >35%) on the Yale Brown Obsessive and Compulsive Scale) or a score of 2 or less on the CGI-I (much or very much improved)
Time Frame
1 month after treatment
Title
score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months
Description
% of improvement compare to baseline
Time Frame
3 months after treatment

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: patients diagnosed with OCD according to DSM V criteria YBOCS score of 16 and above, stable (<20% of variation) during at least one month. have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose. age between 18 and 70 voluntary and competent to consent Exclusion Criteria: Major depressive disorder diagnosed with the DSM V criteria with a MADRS score >30 (actual) schizophrenia and other psychotic disorder drugs or alcohol abuse acutely suicidal significant head injury, or of any neurosurgical procedure with implanted material pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bation Remy, MD
Phone
33437915565
Email
remy.bation@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bation Remy, MD
Organizational Affiliation
CH le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
remy bation, MD
Phone
33437915565
Email
remy.bation@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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tDCS as an add-on Treatment in SSRI-resistant OCD

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