RecruitingNot ApplicableNCT07113652

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


Sponsor

Shanghai Mental Health Center

Enrollment

18 participants

Start Date

Aug 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing temporal interference stimulation (TIS) — a non-invasive brain stimulation method that uses two intersecting electrical fields to target deep brain areas without surgery — as a treatment for obsessive-compulsive disorder (OCD). OCD that hasn't responded to medications is difficult to treat, and TIS may offer a new option. **You may be eligible if...** - You are between 18 and 50 years old - You have a confirmed OCD diagnosis (by DSM-5 criteria) - Your OCD symptoms are severe (Y-BOCS score of 20 or above) - You have tried at least two adequate courses of SSRI medications (common antidepressants used for OCD) without enough benefit - If currently on SSRIs, your dose has been stable for at least 8 weeks - You have at least 9 years of education **You may NOT be eligible if...** - You have any other DSM-5 psychiatric diagnosis (except OCD-related personality disorder) - You have received electroconvulsive therapy in the past 6 months or other brain stimulation recently - You have a neurological disorder or significant medical illness - You have metal implants (pacemaker, stents, cochlear implants) - You are pregnant or planning to become pregnant 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

DEVICETI 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

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NCT07113652


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