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

Shanghai Mental Health Center

Status: Completed

Conditions: Obsessive-Compulsive Disorder

Treatments: Device: Sham tDCS; Device: high-definition transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04086446

SMHC-OCD-004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: 18-50 years old;
• DSM-5 criteria for OCD;
• Y-BOCS total score > or = 16, discontinued medication for at least 8 weeks before tDCS stimulation.
• >or＝9 years education

Exclusion criteria

• Any axis I psychiatric disorder comorbidity
• The inability to receive tDCS because of metallic implants, or history of seizures，or 3.history of head injury, or history of neurosurgery.
• Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
• Any current significant medical condition.
• serious suicide risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups

active tDCS

Active Comparator group

Description:

Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.

Treatment:

Device: high-definition transcranial direct current stimulation

sham tDCS

Sham Comparator group

Description:

The sham transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.

Treatment:

Device: Sham tDCS