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

Shanghai Mental Health Center

Status: Enrolling

Conditions: Obsessive-Compulsive Disorder (OCD)

Treatments: Device: TI stimulation device (nerviox-1000）

Study type: Interventional

Funder types: Other

Identifiers

NCT07113652

SMHC-OCD-018

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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18 participants in 3 patient groups

Nucleus Accumbens Group(NAcc)-Bed Nucleus of the Stria Terminalis Group(BNST)-Exploratory group

Other group

Description:

Participants 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.

Treatment:

Device: TI stimulation device (nerviox-1000）

Bed Nucleus of the Stria Terminalis Group(BNST)-Nucleus Accumbens Group(NAcc)-Exploratory group

Other group

Description:

Participants 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.

Treatment:

Device: TI stimulation device (nerviox-1000）

Sham Group-NAcc Group or BNST Group-Exploratory group

Other group

Description:

Participants 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.

Treatment:

Device: TI stimulation device (nerviox-1000）