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).

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Device: TI stimulation device (nerviox-1000）

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Wang, PhD,MD; Phone Number: +86 34773516; Email: wangzhen@smhc.org.cn

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Mental Health Center
    • Contact: Zhen Wang, Phd, MD; Phone Number: +86 34773516; Email: wangzhen@smhc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bilateral Amygdala Group (BLA-TI); Open-label, single-arm. Participants receive active Temporal Interference (TI) stimulation targeting the bilateral amygdala. Stimulation is delivered twice daily (20 minutes per session) for 7 consecutive days. Parameters: carrier frequencies 2000 Hz and 2160 Hz, envelope frequency 160 Hz, intensity 3-4 mA (adjusted to individual tolerance). Target localization is performed using each participant's MRI data to construct an individualized 3D head model, generating scalp stimulation coordinates for the bilateral amygdala.

Device: TI stimulation device (nerviox-1000）; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, immediately post-treatment (Day 7), and at follow-up visits (Week 1, Week 4, Month 3 post-treatment)

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: SMHC-PTSD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No