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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Mental Health Center

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • TI stimulation device (nerviox-1000)

    Device

    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.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Nucleus Accumbens Group(NAcc)-Bed Nucleus of the Stria Terminalis Group(BNST)-Exploratory groupOther 1 intervention
Group B: Bed Nucleus of the Stria Terminalis Group(BNST)-Nucleus Accumbens Group(NAcc)-Exploratory groupOther 1 intervention
Group C: Sham Group-NAcc Group or BNST Group-Exploratory groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
phase-specific baseline and 1 week after the end of each phase of TI treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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