Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)
NCT ID: NCT02743715
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2016-04-30
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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 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.
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
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Roseli Gedanke Shavitt
MD, PhD Department & Institute of Psychiatry Obsessive-Compulsive Spectrum Disorders Program University of Sao Paulo Medical School, Brazil
Locations
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USP
São Paulo, , Brazil
Countries
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References
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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.
Other Identifiers
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FRONT2016
Identifier Type: -
Identifier Source: org_study_id