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
1 other identifier
interventional
18
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedStudy Start
First participant enrolled
August 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 10, 2026
August 1, 2025
1.8 years
August 6, 2025
March 7, 2026
Conditions
Outcome Measures
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.
phase-specific baseline and 1 week after the end of each phase of TI treatment
Study Arms (3)
Nucleus Accumbens Group(NAcc)-Bed Nucleus of the Stria Terminalis Group(BNST)-Exploratory group
OTHERParticipants assigned to NAcc-BNST group will receive stimulation targeting the NAcc in Phase 1 and the BNST in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala.
Bed Nucleus of the Stria Terminalis Group(BNST)-Nucleus Accumbens Group(NAcc)-Exploratory group
OTHERParticipants assigned to BNST-NAcc group will receive stimulation targeting the BNST in Phase 1 and the NAcc in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala.
Sham Group-NAcc Group or BNST Group-Exploratory group
OTHERParticipants assigned to the Sham-NAcc or Sham-BNST groups will receive sham stimulation in Phase 1, followed by active stimulation targeting the NAcc or the BNST in Phase 2. During the exploratory phase, based on participants' preferences, they will be randomly allocated to receive stimulation targeting one of the following regions: the caudate nucleus, the putamen, or the amygdala.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice-president
Study Record Dates
First Submitted
August 6, 2025
First Posted
August 11, 2025
Study Start
August 17, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 10, 2026
Record last verified: 2025-08