The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder
Shanghai Mental Health Center
5 participants
Jun 8, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07644338