NCT04086446

Transcranial Direct Current Stimulation (tDCS) in the Treatment of Drug-naïve Obsessive-compulsive Disorder(OCD)

A Randomized Clinical Trial of Transcranial Direct Current Stimulation(tDCS) Treatment for Drug-naïve Obsessive-Compulsive Disorder(OCD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the possible therapeutic effects of Transcranial Direct Current Stimulation (tDCS) in drug-naïve obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by magnetic resonance imaging (MRI),transcranial magnetic stimulation and electroencephalography (TMS-EEG).

Detailed description

The purpose of this study is to examine the efficacy of tDCS over orbitofrontal cortex (OFC) in treatment of drug-naïve OCD patients. 60 drug-naïve OCD patients will be randomized into two groups (i.e. active or sham stimulation). tDCS stimulation will be performed once a day, five times a week, for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. The patients will also receive MRI scan and TMS-EEG.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DEVICE	high-definition transcranial direct current stimulation	The tDCS device will deliver a direct current of 1.5mA during 20 minutes. Cathode electrode will be localized in front of the right OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8)
DEVICE	Sham tDCS	The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the first and last 15 seconds.

Timeline

• Start date: 2019-11-05
• Primary completion: 2024-08-30
• Completion: 2024-12-30
• First posted: 2019-09-11
• Last updated: 2025-05-15

Locations

1 site across 1 country: China