Post-traumatic Stress Disorder (PTSD)NCT07644338
The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder
A study testing TI stimulation device (nerviox-1000） in people with Post-traumatic Stress Disorder (PTSD), run by Shanghai Mental Health Center at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- TI stimulation device (nerviox-1000）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, 200030
Zhen Wang, Phd, MD, +86 34773516, wangzhen@smhc.org.cn
About this study
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).
Read the 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.
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Being tested
- TI stimulation device (nerviox-1000）
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TI stimulation device (nerviox-1000） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately post-treatment (Day 7), and at follow-up visits (Week 1, Week 4, Month 3 post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start8 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644338
- Sponsor's protocol ID
- SMHC-PTSD-001
- Status last verified
- May 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Temporal Interference Stimulation in the Treatment of Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07644338
- Acronym / sponsor ID
- SMHC-PTSD-001
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral Amygdala Group (BLA-TI) | Experimental | Device: TI stimulation device (nerviox-1000）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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Bilateral Amygdala Group (BLA-TI) |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Post-traumatic Stress Disorder (PTSD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI stimulation device (nerviox-1000） in people with Post-traumatic Stress Disorder (PTSD), run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Wang, PhD,MD (+86 34773516, wangzhen@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.