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

Obsessive Compulsive Disorder (OCD)

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

Inclusion Criteria5

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 Criteria7

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

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.