Major Depressive DisorderNCT06477276
Amygdala TIS for Depression
A study testing Nervio-X in people with Major Depressive Disorder, run by Ruijin Hospital at 3 sites in China.
Trial summary
The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. 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?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 3 sitesChina
- Study dates
- 24 Jul 2024to 1 May 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 disorders such as schizophrenia, 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
3 sites in 1 country.
China3 sites
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shanghai East Hospital
Shanghai
Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University)
Tianjin
About this study
Official title: A Multicenter, Randomized, Controlled, Double-Blind Trial on the Efficacy and Safety of Amygdala Temporal Interference Stimulation for the Treatment of Depression.
The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.
- Conditions
- Major Depressive Disorder
- Being tested
- Nervio-X
- Keywords
- Deep Brain Stimulation, Non-invasive, TI, Amygdala, Temporal Interference
- 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 | 5 sessions will be delivered in 3 weeks Receives: Device: Nervio-X |
| Controlled TI | Sham comparator | 5 sessions will be delivered in 3 weeks Receives: Device: Nervio-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
Measured: 4 weeks
Secondary outcomes (7)
Hamilton Depression Rating Scale (17-item version)
Measured: Baseline, 1 week, 4 weeks and 8 weeks
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
Measured: Baseline, 1 week and 8 weeks
Snaith-Hamilton Pleasure Scale
The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions.
Measured: Baseline, 1 week, 4 weeks and 8 weeks
Hamilton Anxiety Rating Scale
Measured: Baseline, 4 weeks and 8 weeks
Pittsburgh Sleep Quality Index
Measured: Baseline, 4 weeks and 8 weeks
36-Item Short Form Health Survey
Measured: Baseline and 8 weeks
World Health Organization Quality of Life Assessment - Brief Version
Measured: Baseline 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 posted27 Jun 2024
- Study start24 Jul 2024
- Primary completion1 May 2025
- Study completion1 May 2025
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.
- More trials run by Ruijin HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Anding Hospital, Shanghai East Hospital
- Responsible party
- Principal investigator, ZHANG CHENCHEHG, Ruijin Hospital
- Investigators
- Yiru Fang, MD PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477276
- Sponsor's protocol ID
- 2024LLSD160-001
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang C, Yang Y, Wang C, Wang L, Sun W, Mu C, Feng Z, Liu N, Guan X, Lu Y, Li S, Zhang C, Li J. Temporal interference stimulation (TIS) for major depressive disorder: right lingual gyrus as a predictor. J Affect Disord. 2026 Jul 15;405:121660. doi: 10.1016/j.jad.2026.121660. Epub 2026 Mar 21.
PubMed 41871633
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Double-Blind Trial on the Efficacy and Safety of Amygdala Temporal Interference Stimulation for the Treatment of Depression.
- ClinicalTrials.gov ID
- NCT06477276
- Acronym / sponsor ID
- 2024LLSD160-001
- Conditions
- Major Depressive Disorder
- Keywords
- Deep Brain Stimulation, Non-invasive, TI, Amygdala, Temporal Interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Tianjin Anding Hospital, Shanghai East Hospital
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 27 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 current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amygdala TI | Experimental | Device: Nervio-X5 sessions will be delivered in 3 weeks |
| Controlled TI | Sham comparator | Device: Nervio-X5 sessions will be delivered in 3 weeks |
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 disorders such as schizophrenia, 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, Controlled TI |
Primary outcome
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
Time frame: 4 weeks
7 secondary outcomes
Hamilton Depression Rating Scale (17-item version)
Time frame: Baseline, 1 week, 4 weeks and 8 weeks
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
Time frame: Baseline, 1 week and 8 weeks
Snaith-Hamilton Pleasure Scale
Time frame: Baseline, 1 week, 4 weeks and 8 weeks
Hamilton Anxiety Rating Scale
Time frame: Baseline, 4 weeks and 8 weeks
Pittsburgh Sleep Quality Index
Time frame: Baseline, 4 weeks and 8 weeks
36-Item Short Form Health Survey
Time frame: Baseline and 8 weeks
World Health Organization Quality of Life Assessment - Brief Version
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 41871633Zhang C, Yang Y, Wang C, Wang L, Sun W, Mu C, Feng Z, Liu N, Guan X, Lu Y, Li S, Zhang C, Li J. Temporal interference stimulation (TIS) for major depressive disorder: right lingual gyrus as a predictor. J Affect Disord. 2026 Jul 15;405:121660. doi: 10.1016/j.jad.2026.121660. Epub 2026 Mar 21.
- 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.
Yiru Fang, MD PhD principal investigator
Ruijin Hospital
3 sites 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 Ruijin Hospital at 3 sites 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: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version) (time frame: 4 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 NCT06477276, 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 19 Jun 2025.