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

Not Applicable

Recruiting

• Conditions: Obsessive Compulsive Disorder (OCD)

• Registration Number: NCT06717165
• Lead Sponsor: Shanghai Mental Health Center

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) in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by electroencephalography (EEG).

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. 120 OCD patients whose symptom were mainly associated with "contamination/clean" will be randomized into three groups (ERP+active tACS, ERP+sham tACS stimulation and waiting list). All patients except those in the waiting list will be received 10 sessions of individual CBT 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). Three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using Y-BOCS at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tDCS+ERP (session 10#). The patients will also receive EEG at each point. The current study aims to explore whether the administration of online tACS together with ERP (tACS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.

Study Timeline

• Study Start: 2024-04-15
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-01
• Study First Posted: 2024-12-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-05
• Primary Completion: 2027-10-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 2 months before entering the study and continued the same medication throughout the study
• No previous exposure to ERP or tACS

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China