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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Active Comparator | 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. |
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| Sham tDCS | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS (transcranial direct current stimulation) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change in baseline Yale-Brown Obsessive Compulsive Scale score | weeks 4,6,9,12 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory symptoms, | baseline, weeks 6 and 12 | |
| Beck Anxiety Inventory | baseline, week 6 and 12 | |
| Global Clinical Impression Scale - improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USP | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27901245 | Derived | 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. |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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randomized, sham-controlled trial
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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
|
| Sham tDCS | Device | 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. |
|
| baseline, week 6 and 12 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |