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Recruiting NCT07644338

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

No phase Interventional Post-traumatic Stress Disorder (PTSD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TI stimulation device (nerviox-1000）.
Who it may be relevant to
Registry conditions: Post-traumatic Stress Disorder (PTSD). Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

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.

Interventions

  • 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.

Primary outcome measures

  • post-traumatic stress disorder symptoms improvement [Time frame: Baseline, immediately post-treatment (Day 7), and at follow-up visits (Week 1, Week 4, Month 3 post-treatment)]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Mental Health Center — Shanghai

Identifiers

NCT: NCT07644338 · SMHC-PTSD-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗