Major Depressive DisorderNCT06461260
Amygdala MRI-TIS for Depression
A study testing Nervio-X in people with Major Depressive Disorder, run by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University at 1 site in China.
Trial summary
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Nervio-X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be aged between 18 and 65, with no gender restrictions;
- A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- HAMD-17 score of 17 or higher;
- Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
- Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form.
Who cannot join
- Eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy;
- Participants must not have a history of seizures or prior episodes of epilepsy;
- The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
- Participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention;
- Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);
- The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;
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- Pregnant or breastfeeding;
- Participants who are concurrently engaged in other clinical interventional trials;
- Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied
Trial locations and contacts
1 site in 1 country.
Chencheng Zhang, MD PhD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality
Jingjing Huang, 021-68306699*1222
About this study
Official title: Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.
- Conditions
- Major Depressive Disorder
- Being tested
- Nervio-X
- Keywords
- Major Depressive Disorder, Deep Brain Stimulation, TI stimulation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nervio-XDevice
An 8-channel TIS device developed by NEURODOME Corporation.
| Study group | Role | What they receive |
|---|---|---|
| Amygdala TI | Experimental | Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days. Receives: Device: Nervio-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD-17
Measured: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary outcomes (10)
HAMA
HAMA is a questionnaire that designed to evaluate the presence and intensity of anxiety symptoms in both clinical and research settings.
Measured: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
SHAPS
The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions.
Measured: Baseline, 4 weeks and 8 weeks
SF-36
Measured: Baseline and 8 weeks
WHOQOL-BREF
Measured: Baseline and 8 weeks
PSQI
Measured: Baseline, 4 weeks and 8 weeks
THINC-it®
THINC-it® is a screening tool for assessment of cognitive functioning in patients with a major depressive episode/disorder
Measured: Baseline, treatment completion day and 8 weeks
Blood sample
Peripheral blood will be collected at baseline and one 4 weeks after treatment for transcriptomic and proteomic studies to explore the molecular mechanisms of temporal interference (TI) in the treatment of depressive disorders and to identify molecular markers for predicting therapeutic efficacy
Measured: Baseline, 4 weeks
GAD-7
Measured: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
QIDS-SR
Measured: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
MADRS
Measured: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start27 May 2024
- Primary completion28 Apr 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Principal investigator, Jingjing Huang, MD, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461260
- Sponsor's protocol ID
- PDJW-2024-001CSA
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng Z, Zhou S, Shi D, Long M, Zhang S, Wu F, Zhang Q, Zhang L, Gong H, Huang J. Exploring the feasibility, safety and preliminary clinical effects of amygdala-targeted temporal interference stimulation for major depressive disorder: a pilot study. BMC Psychiatry. 2026 Jul 23;26(1):780. doi: 10.1186/s12888-026-08439-6.
PubMed 42864635
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression
- ClinicalTrials.gov ID
- NCT06461260
- Acronym / sponsor ID
- PDJW-2024-001CSA
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Deep Brain Stimulation, TI stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji UniversityUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- 27 May 2024 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 14 Jun 2024 (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.
The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amygdala TI | Experimental | Device: Nervio-XRight amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be aged between 18 and 65, with no gender restrictions;
- A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- HAMD-17 score of 17 or higher;
- Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
- Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form.
Key exclusion criteria (9 listed)
- Eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy;
- Participants must not have a history of seizures or prior episodes of epilepsy;
- The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
- Participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention;
- Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);
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 |
|---|---|---|
| Nervio-XAn 8-channel TIS device developed by NEURODOME Corporation. | Device | Amygdala TI |
Primary outcome
HAMD-17
Time frame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
10 secondary outcomes
HAMA
Time frame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
SHAPS
Time frame: Baseline, 4 weeks and 8 weeks
SF-36
Time frame: Baseline and 8 weeks
WHOQOL-BREF
Time frame: Baseline and 8 weeks
PSQI
Time frame: Baseline, 4 weeks and 8 weeks
THINC-it®
Time frame: Baseline, treatment completion day and 8 weeks
Blood sample
Time frame: Baseline, 4 weeks
GAD-7
Time frame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
QIDS-SR
Time frame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
MADRS
Time frame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 42864635Zeng Z, Zhou S, Shi D, Long M, Zhang S, Wu F, Zhang Q, Zhang L, Gong H, Huang J. Exploring the feasibility, safety and preliminary clinical effects of amygdala-targeted temporal interference stimulation for major depressive disorder: a pilot study. BMC Psychiatry. 2026 Jul 23;26(1):780. doi: 10.1186/s12888-026-08439-6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chencheng Zhang, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nervio-X in people with Major Depressive Disorder, run by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingjing HUANG, MD PhD (021-68306699*1222, jjhuang_att@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD-17 (time frame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461260, which also lists 1 linked publication.
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 14 Jun 2024.