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

NCT04086446 | Completed

• 1 other identifier: SMHC-OCD-004
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score

  It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.

  Up to 3 months

Secondary Outcomes (6)

• Change in Obsessive Compulsive Inventory-Revised(OCI-R)

  Up to 3 months

• Change in Beck Depression Inventory(BDI)

  Up to 3 months

• Change in Beck Anxiety Inventory (BAI)

  Up to 3 months

• Change in Perceived Stress Scale(PSS)

  Up to 3 months

• Change in Pittsburgh sleep quality index(PSQI)

  Up to 3 months

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

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

Device: high-definition transcranial direct current stimulation

sham tDCS

SHAM COMPARATOR

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

Device: Sham tDCS

Interventions

high-definition transcranial direct current stimulation 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)

active tDCS

Sham tDCS 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.

sham tDCS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Zhen Wang, PhD,MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 11, 2019
• Study Start: November 5, 2019
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)