- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02743715
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
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São Paulo, Brazil
- USP
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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
16 years to 63 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.
|
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.
|
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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Depression Inventory symptoms,
Time Frame: baseline, weeks 6 and 12
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baseline, weeks 6 and 12
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Beck Anxiety Inventory
Time Frame: baseline, week 6 and 12
|
baseline, week 6 and 12
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Global Clinical Impression Scale - improvement
Time Frame: baseline, week 6 and 12
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baseline, week 6 and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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
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.
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