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

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

• Age 18-50 years, male or female
• 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
• If currently receiving psychiatric medication, the dosage must be stable for at least 4 weeks prior to enrollment
• At least 9 years of education (junior high school or above)

Exclusion criteria

• Any DSM-5 diagnosis other than PTSD, depressive disorder, or anxiety disorder
• PTSD symptoms too severe to complete required assessments
• Received electroconvulsive therapy (ECT) within the past 6 months
• Received any other form of neuromodulation within the past 2 months (see Item 3 for ECT)
• Severe medical illness or any condition that may induce seizures or intracranial hypertension (e.g., cardiovascular or respiratory diseases)
• History of neurological disorders (e.g., epilepsy, cerebrovascular accident) or brain injury/surgery
• Presence of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or any other MRI-incompatible implants
• Current significant suicidal behavior risk per investigator judgment
• Pregnancy or planning to become pregnant during the study period
• Initiation of structured psychotherapy for PTSD within 3 months prior to screening, with expected change during the 10-week treatment period