RECRUITINGINTERVENTIONAL

The Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder

Exploring the Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder

About This Trial

This study aims to evaluate the efficacy of Temporal Interference (TI) stimulation in treating patients with obsessive-compulsive disorder (OCD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) and electroencephalography (EEG).

Who May Be Eligible (Plain English)

Who May Qualify: - 18-50 years old - Diagnosis of OCD per DSM-5 - Y-BOCS score ≥20 - Have a documented history of at least two adequate trials of selective serotonin reuptake inhibitors (SSRIs). If currently receiving SSRI treatment, the dosage must be stable for at least 8 weeks prior to enrollment - With at least 9 years of education Who Should NOT Join This Trial: - Any DSM-5 diagnosis other than OCD (except OCPD) - OCD symptoms too severe to complete assessments - Received electroconvulsive therapy (ECT) within the past 6 months - Received other forms of neuromodulation within the past 2 months（see Item 3 for ECT） - Severe medical illness or seizure risk (e.g., cardiovascular, respiratory conditions) - Neurological disorders or history of brain injury/surgery - MRI-incompatible implants (e.g., pacemaker, stents, cochlear implants). - Current suicidal risk per investigator judgment - Pregnant or planning pregnancy during the study - Started structured OCD psychotherapy within 3 months, with expected change during treatment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 18-50 years old * Diagnosis of OCD per DSM-5 * Y-BOCS score ≥20 * Have a documented history of at least two adequate trials of selective serotonin reuptake inhibitors (SSRIs). If currently receiving SSRI treatment, the dosage must be stable for at least 8 weeks prior to enrollment * With at least 9 years of education Exclusion Criteria: * Any DSM-5 diagnosis other than OCD (except OCPD) * OCD symptoms too severe to complete assessments * Received electroconvulsive therapy (ECT) within the past 6 months * Received other forms of neuromodulation within the past 2 months（see Item 3 for ECT） * Severe medical illness or seizure risk (e.g., cardiovascular, respiratory conditions) * Neurological disorders or history of brain injury/surgery * MRI-incompatible implants (e.g., pacemaker, stents, cochlear implants). * Current suicidal risk per investigator judgment * Pregnant or planning pregnancy during the study * Started structured OCD psychotherapy within 3 months, with expected change during treatment

Treatments Being Tested

DEVICE

TI stimulation device (nerviox-1000）

The TI stimulation device (nerviox-1000) delivers temporally interfering electrical fields with a 130 Hz envelope frequency, generated by high-frequency carrier waves. The stimulation is applied for 20 minutes per session, with a peak current of 3-4 mA per channel, adjusted based on individual tolerance. The stimulation targets include the nucleus accumbens, bed nucleus of the stria terminalis, amygdala, caudate nucleus, and putamen. Stimulation is administered twice daily, with each treatment phase lasting 7 consecutive days. Sham stimulation uses identical electrode placement and setup as active stimulation. A brief 30-second ramp-up is applied to mimic real stimulation, followed by rapid reduction to 0 mA or minimal current. A 1 mA "tail" current is delivered in the final 30 seconds to simulate the tapering effect of active stimulation.

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China