RecruitingNot ApplicableNCT06717165

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

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)


Sponsor

Shanghai Mental Health Center

Enrollment

62 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding brain stimulation (using transcranial alternating current stimulation, or tACS — a non-invasive technique that delivers gentle electrical pulses to the scalp) to cognitive behavioral therapy (CBT) can improve outcomes in people with obsessive-compulsive disorder (OCD). **You may be eligible if...** - You are 18–60 years old with a diagnosis of OCD - You have at least 9 years of education - Your OCD symptoms score 16 or higher on the Y-BOCS scale - You are either medication-free or on a stable medication dose for at least 8 weeks - You have not had a previous full course of CBT or ERP (Exposure and Response Prevention) **You may NOT be eligible if...** - You have other serious neurological or psychiatric conditions (besides OCD) - Your OCD is so severe that you cannot complete assessments - You are at serious risk of suicide - You are pregnant or planning to become pregnant - You are taking anti-epileptic medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTERP 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).

COMBINATION_PRODUCTERP 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.


Locations(1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

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NCT06717165


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