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
Qualifiers
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
Treatments tested in this trial
- TI stimulation device (nerviox-1000）
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov