Efficacy and Mechanism of Augmentation of Cognitive Behavioral Therapy With Transcranial Alternating Current Stimulation(tACS) for Obsessive-Compulsive Disorder (OCD)

July 29, 2025 updated by: Zhen Wang, Shanghai Mental Health Center

A Randomized, Double-Blind, Clinical Trial to Study the Efficacy and Mechanisms of Transcranial Alternating Current Stimulation (tACS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)

This study aims to evaluate the feasibility and clinical outcome of the Exposure-based Cognitive-Behavioral Therapy (CBT) concurrent with Transcranial Alternating Current Stimulation (tACS) using individualized stimulation frequency in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT (ERP) combined with tACS over the prefrontal cortex (mPFC) in treatment of OCD patients. 62 OCD patients will be randomized into two groups (ERP+active tACS, ERP+sham tACS stimulation). All patients will be received 10 sessions of individual ERP in a two-month period, including 8 sessions of concurrent tACS with ERP (tACS+ERP). Based on the EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency).

The treatment program consists of a total of 10 sessions, with the first and last sessions being psychological therapy only. The middle eight sessions will involve concurrent transcranial alternating current stimulation (tACS) and exposure and response prevention (ERP). The timing of assessments is designed to capture changes in symptom severity during the intervals between consecutive combined treatment sessions.

Three independent evaluators will assess the severity of patients' obsessive-compulsive symptoms using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at four time points:

Baseline assessment (prior to the start of treatment); After the first combined session (Session 2) and before the second combined session (Session 3); After the fourth combined session (Session 5) and before the fifth combined session(Session 6); After the eighth combined session (Session 9) and before the final treatment session (Session 10).

Patients will also undergo electroencephalography (EEG) assessments at each evaluation time point. The current study aims to explore whether the administration of individualized stimulation frequency tACS in conjunction with ERP can enhance the efficacy of ERP, providing early evidence for revealing the potential neural mechanisms underlying this treatment. Additionally, participants will undergo magnetic resonance imaging (MRI) scans at treatment baseline and after the completion of the full course of treatment.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

The investigators recruited outpatient adults with OCD confirmed by the Mini-International Neuropsychiatric Interview (MINI). The following inclusion and exclusion criteria were also applied:

Inclusion Criteria:

  • 18-60 years old
  • With at least 9 years of education
  • Y-BOCS score ≥16
  • No history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary)
  • Medication-free or had received stable medication for at least 8 weeks before entering the study and continued the same medication throughout the study

Exclusion Criteria:

  • History of serious medical, neurological illness or other psychotic disorders other than OCD
  • OCD symptoms are severe, preventing the patient from completing the required assessment and examination
  • Serious suicide risk
  • Women who are pregnant or planning to become pregnant
  • Currently taking antiepileptic medication
  • Clinically significant physical illnesses or laboratory test abnormalities that have clinical significance
  • Previous completion of a full course of CBT/ERP treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active tACS+exposure based CBT
The exposure and response prevention (ERP) treatment concurrently with an anode transcranial alternating current stimulation over the mPFC will be applied 8 times (tACS+ERP, 8 sessions) in the whole treatment.
Combination product: ERP combined with high-definition active tACS
The active tACS +ERP referred to a period of tACS applied in the first 20 minutes of the ERP treatment (the tACS device was activated when ERP began and deactivated automatically while ERP continued). The total treatment phase lasted eight weeks and included ten sessions with experienced psychotherapists following a specific manual for the tACS+ERP treatment. Based on the EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency). Anode electrode will be localized in front of the mPFC on the Fz point according to the EEG international reference. Four cathode electrodes will be placed around (i.e. AFz, Fcz, F1, F2).
Sham Comparator: sham tACS +exposure based CBT
the exposure and response prevention (ERP) treatment concurrently with an sham transcranial alternating current stimulation over the mPFC will be applied 8 times (sham tACS+ERP, 8 sessions) in the whole treatment.
Combination product: ERP combined with sham tACS
Patients will get the same CBT setting as the active tACS group and they were applied the sham tACS cocurrently with ERP. The sham tACS device is the same as the active comparator's except that the sham tACS will only deliver a current stimulation for the first and last 15 seconds in order to produce somatic sensation in patients similar to that induced by the active tACS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the differences in treatment efficacy between active and sham transcranial alternating current stimulation (tACS) concurrent with exposure and response prevention (ERP)(tACS+ERP) in patients with obsessive-compulsive disorder (OCD).
Time Frame: baseline, 2weeks, 4weeks,8 weeks (baseline, after Session 2, 5, 10)

The primary outcome measure of this study is the change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores from baseline at the completion of the 8th tACS + ERP treatment.

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)：The total score of the scale ranges from 0 to 40, with higher scores indicating more severe symptoms.
baseline, 2weeks, 4weeks,8 weeks (baseline, after Session 2, 5, 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Principal Investigator: Zhen Wang, PhD, MD, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 1, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMHC-OCD-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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