Obsessive-Compulsive Disorder (OCD)
Conditions
Brief 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.
Interventions
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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obsessive-compulsive symptoms improvement | phase-specific baseline and 1 week after the end of each phase of TI treatment | 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. |
Countries
China
Contacts
CONTACTZhen Wang, PhD,MD
Outcome results
None listed