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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleus Accumbens Group(NAcc)-Bed Nucleus of the Stria Terminalis Group(BNST)-Exploratory group | Other | 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. |
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| Bed Nucleus of the Stria Terminalis Group(BNST)-Nucleus Accumbens Group(NAcc)-Exploratory group | Other | 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. |
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| Sham Group-NAcc Group or BNST Group-Exploratory group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Wang, PhD,MD | Contact | +86 34773516 | wangzhen@smhc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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