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

NCT06717165 | Recruiting

• 1 other identifier: SMHC-OCD-013
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

cognitive-behavioral therapy; exposure and response prevention; transcranial alternating current stimulation

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

Study Arms (2)

active tACS+exposure based CBT

ACTIVE COMPARATOR

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

sham tACS +exposure based CBT

SHAM COMPARATOR

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

Interventions

ERP combined with high-definition active tACS COMBINATION_PRODUCT

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).

active tACS+exposure based CBT

ERP combined with sham tACS COMBINATION_PRODUCT

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.

sham tACS +exposure based CBT

Eligibility Criteria

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

You may not qualify if:

• years old
• With at least 9 years of education
• Y-BOCS score ≥16
• Medication-free or had received stable medication for at least 8 weeks before entering the study and continued the same medication throughout the study
• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

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

Central Study Contacts

Zhen Wang, PhD, MD

CONTACT

+86 34773516; wangzhen@smhc.org.cn

Zhen Wang, PhD, MD

CONTACT

+86 64387250; wangzhen@smhc.org.cn

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: December 1, 2024
• First Posted: December 4, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)