Exploring the Efficacy of Accelerated Transcranial Direct Current Stimulation (tDCS) as Adjunct to Pharmacotherapy in the Treatment of Obsessive-compulsive Disorder

NCT07115615 | Not Yet Recruiting

• 1 other identifier: SMHC-YG-OCD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the decision-making ability and therapeutic effects of accelerated Transcranial Direct Current Stimulation (tDCS) as adjunct to pharmacotherapy in obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by EEG and MRI.

Conditions

Obsessive Compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (1)

• Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale(Y-BOCS)

  The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.

  Up to 5 weeks

Secondary Outcomes (3)

• The Beck Depression Inventory-II(BDI-II)

  Up to 5 weeks

• The Beck Anxiety Inventory (BAI)

  Up to 5 weeks

• Side-effect questionnaire

  Up to 5 weeks

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

Cathode transcranial direct current stimulation over the right OFC will be applied four times a day (2 hours interval), 5 days a week, for 1 week.

Device: high-definition transcranial direct current stimulation

sham tDCS

SHAM COMPARATOR

The sham transcranial direct current stimulation over the right OFC will be applied four times a day (2 hours interval), 5 days a week, for 1 week.

Device: Sham tDCS

Interventions

high-definition transcranial direct current stimulation DEVICE

The tDCS device will deliver a direct current of 2mA 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

To demonstrate the same stimulation sensation as under real conditions, only 40 seconds of real stimulation (2mA) are given at the beginning of the treatment. In the remaining 20 minutes, only about 15ms of short current pulses of 110uA occur every 550ms.

sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years old, Han ethnicity, right-handed
• DSM-5 criteria for OCD;
• Y-BOCS total score ≥16, receiving stable medication for at least 4 weeks before tDCS stimulation.
• Years of education ≥9.

You may not qualify if:

• Any axis I psychiatric disorder comorbidity
• Severe obsessive-compulsive symptoms that render the patient unable to complete required assessment procedures.
• Previous treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS).
• Severe somatic diseases or any physical conditions that may induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, etc.
• History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or traumatic brain injury/brain surgery.
• Implantation of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or other internal medical devices.
• Women who are pregnant or planning to become pregnant in the near future.
• Serious suicide risks.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Qing Zhao, PhD,MD

CONTACT

+86 18516539730; zhaoqing@smhc.org.cn

Qing Wang, PhD

CONTACT

+86 19821243355; vincent.w.qing@gmail.com

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: Attending Physician

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-07

Locations

CN (1)