NCT07113652

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This randomized, blind, multi-phase clinical trial aims to evaluate the efficacy of Temporal Interference (TI) stimulation in patients with treatment obsessive-compulsive disorder (OCD), and to compare the effects of stimulating different brain regions. The study includes three phases: * Phase 1: Patients are randomly assigned to receive either sham stimulation, bilateral nucleus accumbens (NAcc) stimulation, or bilateral bed nucleus of the stria terminalis (BNST) stimulation. * Phase 2: Non-responders from Phase 1 enter a second phase, receiving stimulation to the opposite target region. Sham participants are re-randomized to NAcc or BNST. * Phase 3 (Exploratory): Remaining non-responders may opt to receive stimulation targeting the caudate nucleus, the putamen, or the amygdala. Stimulation is delivered twice daily for 7 days in each phase, followed by follow-up assessments for up to 4 weeks. Comprehensive clinical assessments, self-reported symptom scales, magnetic resonance imaging (MRI), electroencephalography (EEG), and cognitive function tests are conducted before and after each phase to ensure data consistency. Additionally, clinical assessments and self-reported scales are repeated 1 week after the end of each treatment phase.

Conditions

• Obsessive-Compulsive Disorder (OCD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-17
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-08-11
• Last updated: 2026-03-10

Locations

1 site across 1 country: China