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Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT) (FRONT)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active tDCS (transcranial direct current stimulation)
Sham tDCS
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Transcranial direct current stimulation, Neuromodulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with OCD according to DSM IV criteria
  • YBOCS score of 16 and above or ≥10 (for the presence of only compulsions or only obsessions)
  • Patients with other psychiatric comorbidities are not excluded, however, OCD should be the most important disease .
  • Age between 18 and 65
  • Patients who failed one or more treatments
  • Patients with no previous treatment for OCD will be treated with one first line treatment before being considered to participate in the tDCS trial.
  • Voluntary and competent to consent

Exclusion Criteria:

  • Other diagnostic axis I whose treatment take precedence over the treatment of OCD (bipolar affective disorder; dependence alcohol; schizophrenia or psychotic disorders; dementia)
  • Presence of other neurological diseases or severe clinical as neurodegenerative diseases, severe aphasia, malignancies activity, epilepsy, previous head injury, congestive heart failure or chronic obstructive pulmonary disease stage III or IV;
  • Presence of severe suicidal ideation (Structured planning suicide or attempted suicide in the past 4 weeks);
  • Pregnancy;
  • Inability to provide informed consent;
  • Specific contraindication to tDCS: ( metal plates on the head, anatomic changes.);
  • In relation to the current use of psychotropic drugs will be permitted, provided they are in doses stable for at least 6 weeks.

Sites / Locations

  • USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Electric current of 2mA delivered to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks.

In this group, the cathode is positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks, without delivery of the electric current.

Outcomes

Primary Outcome Measures

change in baseline Yale-Brown Obsessive Compulsive Scale score

Secondary Outcome Measures

Beck Depression Inventory symptoms,
Beck Anxiety Inventory
Global Clinical Impression Scale - improvement

Full Information

First Posted
April 7, 2016
Last Updated
December 26, 2020
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02743715
Brief Title
Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)
Acronym
FRONT
Official Title
Randomized, Sham-Controlled Trial of Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Neuromodulation techniques for the treatment of Obsessive-Compulsive Disorder (OCD) have expanded with the greater understanding of the brain circuits involved in this disorder. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has been studied as an alternative for strategy for treatment-resistant OCD. The main study is a randomized, sham-controlled, double-blinded trial tDCS for OCD patients unresponsive to cognitive-behavioral therapy and/or selective serotonin reuptake inhibitors. Forty-four patients will be randomized to two groups: active or simulated intervention. The intervention consisted of delivering an electric current of 2mA to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, and the anode positioned in the deltoid (neutral region), during 30-minutes, for four consecutive weeks. The primary outcome was the reduction in baseline YBOCS scores before and after of tDCS treatment. Secondary outcomes include measures of depressive and anxiety symptoms, genetic markers, motor cortical excitability and performance in neurocognitive tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, Transcranial direct current stimulation, Neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, sham-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
all study staff were blind to the participant's condition; only the neuromodulation staff, external to the study team, were aware of the participant's treatment group
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Electric current of 2mA delivered to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
In this group, the cathode is positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks, without delivery of the electric current.
Intervention Type
Device
Intervention Name(s)
Active tDCS (transcranial direct current stimulation)
Intervention Description
An electrical current of 2mA is delivered to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
The cathode is positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in a 30-minute session, 5 days a week (Mondays through Fridays) for four consecutive weeks, without delivery of the electric current.
Primary Outcome Measure Information:
Title
change in baseline Yale-Brown Obsessive Compulsive Scale score
Time Frame
weeks 4,6,9,12
Secondary Outcome Measure Information:
Title
Beck Depression Inventory symptoms,
Time Frame
baseline, weeks 6 and 12
Title
Beck Anxiety Inventory
Time Frame
baseline, week 6 and 12
Title
Global Clinical Impression Scale - improvement
Time Frame
baseline, week 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with OCD according to DSM IV criteria YBOCS score of 16 and above or ≥10 (for the presence of only compulsions or only obsessions) Patients with other psychiatric comorbidities are not excluded, however, OCD should be the most important disease . Age between 18 and 65 Patients who failed one or more treatments Patients with no previous treatment for OCD will be treated with one first line treatment before being considered to participate in the tDCS trial. Voluntary and competent to consent Exclusion Criteria: Other diagnostic axis I whose treatment take precedence over the treatment of OCD (bipolar affective disorder; dependence alcohol; schizophrenia or psychotic disorders; dementia) Presence of other neurological diseases or severe clinical as neurodegenerative diseases, severe aphasia, malignancies activity, epilepsy, previous head injury, congestive heart failure or chronic obstructive pulmonary disease stage III or IV; Presence of severe suicidal ideation (Structured planning suicide or attempted suicide in the past 4 weeks); Pregnancy; Inability to provide informed consent; Specific contraindication to tDCS: ( metal plates on the head, anatomic changes.); In relation to the current use of psychotropic drugs will be permitted, provided they are in doses stable for at least 6 weeks.
Facility Information:
Facility Name
USP
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27901245
Citation
Silva RM, Brunoni AR, Miguel EC, Shavitt RG. Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder: report on two cases and proposal for a randomized, sham-controlled trial. Sao Paulo Med J. 2016 Sep-Oct;134(5):446-450. doi: 10.1590/1516-3180.2016.0155010716.
Results Reference
derived

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Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)

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