Post-traumatic Stress Disorder (PTSD)
Conditions
Brief summary
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).
Detailed description
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.
Interventions
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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-50 years, male or female 2. Diagnosis of PTSD per DSM-5 (assessed by CAPS-5), with symptom duration of at least 3 months, and PTSD as the current primary diagnosis; comorbid depressive disorder or anxiety disorder is allowed 3. If currently receiving psychiatric medication, the dosage must be stable for at least 4 weeks prior to enrollment 4. At least 9 years of education (junior high school or above)
Exclusion criteria
1. Any DSM-5 diagnosis other than PTSD, depressive disorder, or anxiety disorder 2. PTSD symptoms too severe to complete required assessments 3. Received electroconvulsive therapy (ECT) within the past 6 months 4. Received any other form of neuromodulation within the past 2 months (see Item 3 for ECT) 5. Severe medical illness or any condition that may induce seizures or intracranial hypertension (e.g., cardiovascular or respiratory diseases) 6. History of neurological disorders (e.g., epilepsy, cerebrovascular accident) or brain injury/surgery 7. Presence of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or any other MRI-incompatible implants 8. Current significant suicidal behavior risk per investigator judgment 9. Pregnancy or planning to become pregnant during the study period 10. Initiation of structured psychotherapy for PTSD within 3 months prior to screening, with expected change during the 10-week treatment period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-traumatic stress disorder symptoms improvement | Baseline, immediately post-treatment (Day 7), and at follow-up visits (Week 1, Week 4, Month 3 post-treatment) | 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. |
Countries
China
Contacts
CONTACTZhen Wang, PhD,MD
Outcome results
None listed