The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder

The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder

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.

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