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

NCT07113652 · Shanghai Mental Health Center
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Official title
Exploring the Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 18 participants
Allocation: randomized
Masking: triple
Age groups: adult
Timeline
Starts: 2025-08-17
Estimated completion: 2027-06
Last updated: 2026-03-10
Interventions
Device: TI stimulation device (nerviox-1000)
Primary outcomes
  • Obsessive-compulsive symptoms improvement (phase-specific baseline and 1 week after the end of each phase of TI treatment)
Sponsor
Shanghai Mental Health Center · other
Contacts & investigators
ContactZhen Wang, PhD,MD · contact · wangzhen@smhc.org.cn · +86 34773516
All locations (1)
Shanghai Mental Health CenterRecruiting
Shanghai, Shanghai Municipality, China
The Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder · TrialPath