The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Mental Health Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
TI stimulation device (nerviox-1000）
DeviceThe 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Bilateral Amygdala Group (BLA-TI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, immediately post-treatment (Day 7), and at follow-up visits (Week 1, Week 4, Month 3 post-treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov