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

December 26, 2020 updated by: Roseli Gedanke Shavitt, University of Sao Paulo

Randomized, Sham-Controlled Trial of Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active tDCS
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.
Device: Active tDCS (transcranial direct current stimulation)
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.
Sham Comparator: Sham tDCS
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.
Device: Sham tDCS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in baseline Yale-Brown Obsessive Compulsive Scale score
Time Frame: weeks 4,6,9,12
weeks 4,6,9,12

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory symptoms,
Time Frame: baseline, weeks 6 and 12
baseline, weeks 6 and 12
Beck Anxiety Inventory
Time Frame: baseline, week 6 and 12
baseline, week 6 and 12
Global Clinical Impression Scale - improvement
Time Frame: baseline, week 6 and 12
baseline, week 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 26, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRONT2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obsessive-Compulsive Disorder

Clinical Trials on Active tDCS (transcranial direct current stimulation)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe