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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Sequential
Treatments tested in this trial
TI stimulation device (nerviox-1000)
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Obsessive-compulsive symptoms improvement
Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a 10-item clinician-rated scale with a total score range of 0 to 40. Higher total scores indicate more severe obsessive-compulsive symptoms.
Sponsors and contacts
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