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

NCT ID: NCT07115615

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-11
• Study Completion Date: 2026-12-31

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.

Detailed Description

The purpose of this study is to examine the decision-making ability and clinical efficacy of accelerated tDCS over orbitofrontal cortex (OFC) as adjunct to pharmacotherapy in treatment of OCD patients.60 OCD patients on stable medication will be randomized into two groups (i.e. active or sham stimulation). Accelerated tDCS stimulation will be performed four times a day, five times a week, for one week. Iowa Gambling Task will be conducted at the baseline, after the one week tDCS and at the 1-month follow-up to evaluate the decision-making ability of OCD patients.The investigators will assess symptom severity before and after one week of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, Clinical Global Impression(CGI), the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), Childhood Trauma Questionnair(CTQ), side-effect questionnaire and other scales will be obtained by a trained investigator.The patients will also receive magnetic resonance imaging (MRI) scan, electroencephalography (EEG).

Conditions

Obsessive Compulsive Disorder (OCD)

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 four times a day (2 hours interval), 5 days a week, for 1 week.

Group Type: ACTIVE_COMPARATOR

high-definition transcranial direct current stimulation

Intervention Type: 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)

sham tDCS

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.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: 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.

Interventions

high-definition transcranial direct current stimulation

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)

Intervention Type: DEVICE

Sham tDCS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18-60 years old, Han ethnicity, right-handed

2. DSM-5 criteria for OCD;

3. Y-BOCS total score ≥16, receiving stable medication for at least 4 weeks before tDCS stimulation.

4. Years of education ≥9.

Exclusion Criteria

1. Any axis I psychiatric disorder comorbidity

2. Severe obsessive-compulsive symptoms that render the patient unable to complete required assessment procedures.

3. Previous treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS).

4. Severe somatic diseases or any physical conditions that may induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, etc.

5. History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or traumatic brain injury/brain surgery.

6. Implantation of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or other internal medical devices.

7. Women who are pregnant or planning to become pregnant in the near future.

8. Serious suicide risks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Qing ZHAO

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Mental Health Center

Shanghai, , China

Countries

China

Central Contacts

Qing Zhao, PhD,MD

Role: CONTACT

zhaoqing@smhc.org.cn

+86 18516539730

Qing Wang, PhD

Role: CONTACT

vincent.w.qing@gmail.com

+86 19821243355

Other Identifiers

SMHC-YG-OCD

Identifier Type: -

Identifier Source: org_study_id