Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06717165

A Randomized, Double-Blind Clinical Trial of Transcranial Alternating Current Stimulation with Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder

Led by Shanghai Mental Health Center · Updated on 2025-08-01

62

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a treatment for adults with obsessive-compulsive disorder (OCD) using a combination of exposure-based cognitive-behavioral therapy (CBT) and transcranial alternating current stimulation (tACS) with individualized stimulation frequencies. The study aims to assess the feasibility and clinical outcomes of this combined approach and to explore the underlying brain mechanisms using magnetic resonance imaging (MRI) and electroencephalography (EEG). This trial uses a randomized, double-blind design to compare active tACS combined with CBT versus sham tACS combined with CBT. Participants will receive a total of 10 therapy sessions over two months. The first and last sessions include only psychological therapy. The eight middle sessions combine exposure and response prevention (ERP) therapy with concurrent tACS or sham tACS applied to the prefrontal cortex. Individualized stimulation frequencies are determined from EEG data, with electrodes placed around specific points on the scalp. The sham tACS mimics sensation but does not deliver ongoing stimulation. Throughout the study, patients will be evaluated at four time points using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) to measure symptom severity. EEG assessments will be performed at each evaluation to monitor brain activity changes. MRI scans will be done at the start and end of treatment to investigate neural changes. This thorough monitoring aims to understand if combining tACS with CBT improves treatment outcomes and the mechanisms behind this effect. The total participation period lasts eight weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 60 years
  • At least 9 years of education
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 16 or higher
  • Diagnosed with OCD confirmed by Mini-International Neuropsychiatric Interview (MINI)
  • No history of serious medical or neurological illness or other psychotic disorders except OCD
  • Medication-free or on stable medication for at least 8 weeks before study and continue same medication during study
Not Eligible

You will not qualify if you...

  • History of serious medical, neurological illness or other psychotic disorders besides OCD
  • OCD symptoms too severe to complete assessments or examinations
  • Serious suicide risk
  • Women who are pregnant or plan to become pregnant
  • Currently taking antiepileptic medication
  • Clinically significant physical illnesses or lab abnormalities
  • Previously completed a full course of CBT or ERP treatment for OCD

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 months

Participants receive 10 individual exposure and response prevention (ERP) therapy sessions over two months. Eight of these sessions include concurrent transcranial alternating current stimulation (tACS) or sham stimulation targeting the prefrontal cortex.

10 therapy sessions

Follow-up

Duration - Assessments occur at baseline, after Sessions 2, 5, and 10

Participants undergo assessments including symptom evaluations and MRI scans at baseline, mid-treatment, and after completion of treatment to monitor clinical outcomes and brain changes.

4 assessment visits including MRI scans

Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China, 200030

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Research Team

Z

Zhen Wang, PhD, MD

Z

Zhen Wang, PhD, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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