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This study aims to evaluate the efficacy and safety of Temporal Interference (TI) stimulation in treating patients with post-traumatic stress disorder (PTSD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) ,magnetoencephalography(MEG),electroencephalography (EEG).
This open-label, single-arm clinical trial aims to evaluate the efficacy and safety of Temporal Interference (TI) stimulation targeting the bilateral amygdala in patients with post-traumatic stress disorder (PTSD).
All enrolled patients receive active TI stimulation delivered twice daily for 20 minutes per session over 7 consecutive days, followed by follow-up assessments for up to 3 months. Comprehensive clinical assessments, self-reported symptom scales, magnetic resonance imaging(MRI), magnetoencephalography(MEG),electroencephalography (EEG), and cognitive function tests are conducted before and after the treatment to ensure data consistency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Amygdala Group (BLA-TI) | Experimental | Open-label, single-arm. Participants receive active Temporal Interference (TI) stimulation targeting the bilateral amygdala. Stimulation is delivered twice daily (20 minutes per session) for 7 consecutive days. Parameters: carrier frequencies 2000 Hz and 2160 Hz, envelope frequency 160 Hz, intensity 3-4 mA (adjusted to individual tolerance). Target localization is performed using each participant's MRI data to construct an individualized 3D head model, generating scalp stimulation coordinates for the bilateral amygdala. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TI stimulation device (nerviox-1000) | Device | The TI stimulation device delivers temporally interfering electrical fields with a 160 Hz envelope frequency, generated by high-frequency carrier waves (2000 Hz and 2160 Hz). 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 target is the bilateral amygdala. Stimulation is administered twice daily, with the treatment phase lasting 7 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| post-traumatic stress disorder symptoms improvement | PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), a clinician-rated structured interview with a total severity score range of 0 to 80. Higher total scores indicate more severe post-traumatic stress symptoms. | Baseline, immediately post-treatment (Day 7), and at follow-up visits (Week 1, Week 4, Month 3 post-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 | 200030 | China |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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