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

NCT06717165 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Mental Health Center

Phase

Not applicable

Started

2024-04-15

Last updated

2025-08-01

Condition(s) studied

Obsessive Compulsive Disorder (OCD)

Investigational drug(s) / intervention(s)

ERP combined with high-definition active tACSERP combined with sham tACS

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).

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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

Primary outcome measure(s)

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 sites (1)

Facility	City	Region	Status
Shanghai Mental Health Center	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06717165 on ClinicalTrials.gov ↗ ← All trials in China