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

NCT07644338 | Recruiting

• 1 other identifier: SMHC-PTSD-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Post-traumatic Stress Disorder (PTSD)

Outcome Measures

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.

  Baseline, immediately post-treatment (Day 7), and at follow-up visits (Week 1, Week 4, Month 3 post-treatment)

Study Arms (1)

Bilateral Amygdala Group (BLA-TI)

EXPERIMENTAL

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）

Interventions

TI stimulation device (nerviox-1000） DEVICE

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.

Bilateral Amygdala Group (BLA-TI)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Zhen Wang, PhD,MD

CONTACT

+86 34773516; wangzhen@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-05

Locations

CN (1)