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

NCT ID: NCT04086446

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2024-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active tDCS

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

Group Type: ACTIVE_COMPARATOR

high-definition transcranial direct current stimulation

Intervention Type: DEVICE

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)

sham tDCS

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

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the first and last 15 seconds.

Interventions

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)

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Zhen Wang

vice-president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Wang, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SMHC-OCD-004

Identifier Type: -

Identifier Source: org_study_id