Major Depressive Disorder (MDD)NCT07059143
6 Weeks Right-Amygdala TIS for Depression
A study testing Nervio-X in people with Major Depressive Disorder (MDD), 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 60 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- 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
- 38 participants
- Where
- 3 sitesChina
- Study dates
- 27 May 2025to 8 Jul 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age : 18 to 60 years (inclusive), any gender.
- Diagnosis : Major depressive episode diagnosed by study physicians according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with no restriction on first-onset or recurrent episodes.
- Symptom Severity : 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 at screening.
- Treatment Stability : Antidepressant regimen must remain unchanged from 30 days prior to signing informed consent through the study duration. Patients using >2 antidepressants or combinations of antidepressant(s) + augmenting agent(s) must be adjusted to ≤2 agents* ≥1 week prior to enrollment.
- Cognitive Capacity : Sufficient literacy and comprehension skills to complete study assessments.
- Compliance : Investigator-confirmed understanding of study objectives/procedures, protocol compliance, and provision of written informed consent.
Who cannot join
- Comorbidities : Major psychiatric disorders (e.g., schizophrenia, bipolar disorder) Significant neurological conditions (e.g., traumatic brain injury, post-neurosurgical status)
- Medical Devices : Intracranial/cardiac metallic implants or electronic medical devices (e.g., pacemakers, deep brain stimulation systems)
- Recent Interventions : Electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within 30 days prior to enrollment
- Clinical Instability : Acute suicidality (e.g., active suicidal ideation with intent) Inability to complete study follow-up per investigator judgment
- Concurrent Trials : Participation in other interventional clinical studies during the trial period
- Reproductive Status : Pregnancy, lactation, or plans for conception during the trial
- Suicide Risk : Score ≥3 on Item 3 of the 17-item Hamilton Depression Rating Scale (HAMD-17)
- Any condition deemed to compromise subject safety or study validity per clinical evaluation
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Affiliated Brain Hospital Of Guangzhou Medical University
Guangdong
Ruijin Hospital
Shanghai
Anding Hospital (Mental Health Center of Tianjin Medical University)
Tianjin
About this study
Official title: A Multicenter Randomized Double-Blind Controlled Trial of Six-Week Transcranial Temporal Interference Stimulation(TIS) Targeting the Right Amygdala for Rapid Alleviation of Depressive Symptoms.
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 (MDD)
- Being tested
- Nervio-X
- Keywords
- Deep Brain Stimulation, Non-invasive, Amygdala, Temporal Interference, TIS
- 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 | 18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks Receives: Device: Nervio-X |
| Controlled TI | Sham comparator | 18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks Receives: Device: Nervio-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (17-item version)
The Hamilton Depression Rating Scale is a widely utilized clinician-administered instrument for assessing depression severity, consisting of 17 items that evaluate core depressive symptoms. Total scores range from 0-52, with established cutoff points: 0-7 (no depression/remission), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (severe depression), and ≥23 (very severe depression). The HAM-D17 demonstrates good internal consistency reliability with Cronbach's alpha values ranging from 0.747 to 0.829.
Measured: Baseline, 6 weeks
Secondary outcomes (8)
Hamilton Depression Rating Scale (17-item version)
The Hamilton Depression Rating Scale is a widely utilized clinician-administered instrument for assessing depression severity, consisting of 17 items that evaluate core depressive symptoms. Total scores range from 0-52, with established cutoff points: 0-7 (no depression/remission), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (severe depression), and ≥23 (very severe depression). The HAM-D17 demonstrates good internal consistency reliability with Cronbach's alpha values ranging from 0.747 to 0.829.
Measured: Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
The QIDS-SR16 is a widely used self-report scale for depressive symptoms, containing 16 items that cover all core symptom criteria for DSM-IV major depression. This scale was developed by Rush et al. for rapid assessment of depression symptom severity. Each item has 4 options with a scoring range of 0-3 points, where 0 = no symptoms or mildest symptoms, and 3 = most severe symptoms. The scale demonstrates good internal consistency (Cronbach's α = 0.86) and exhibits high sensitivity for detecting symptom fluctuations.
Measured: Baseline, 1 week, 2 weeks, 6weeks, 10 weeks
THINC-it®: An Integrated Tool for Cognitive Dysfunction Screening
THINC-it® is a comprehensive, digitally-based cognitive screening instrument specifically designed to assess cognitive dysfunction in adults with major depressive disorder (MDD). This validated tool comprises five integrated components: four objective cognitive tests (Codebreaker, Trials, Spotter, and SymbolCheck) that evaluate processing speed, executive function, attention, and working memory, plus the PDQ-5-D self-report questionnaire for subjective cognitive assessment. The entire battery requires approximately 10-12 minutes to complete and demonstrates robust psychometric properties with high sensitivity to cognitive changes over time.
Measured: Baseline, 2 weeks, 6 weeks, 10 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self-report instrument designed to assess anhedonia (reduced capacity to experience pleasure) in clinical and research settings. Each item is rated on a 4-point Likert scale (1-4), yielding a total score range of 14-56, where higher scores indicate greater levels of anhedonia. The scale demonstrates excellent internal consistency with Cronbach's alpha values ranging from 0.84 to 0.88 and shows satisfactory test-retest reliability (ICC=0.70).
Measured: Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks
Hamilton Anxiety Rating Scale (HAMA)
The Hamilton Anxiety Rating Scale (HAMA) is a 14-item clinician-administered instrument developed by Hamilton in 1959 to assess anxiety symptom severity in clinical populations. Each item is rated on a 5-point scale (0-4), with total scores ranging from 0-56, where higher scores indicate greater anxiety severity. Score interpretation follows established cutoffs: 0-17 (mild anxiety), 18-24 (mild to moderate anxiety), and 25-30 (moderate to severe anxiety) . The scale demonstrates excellent internal consistency reliability with Cronbach's alpha values consistently ranging from 0.77 to 0.92.
Measured: Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to assess sleep quality and disturbances over a one-month period. The scale comprises seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0-3, yielding a global PSQI score ranging from 0-21, where higher scores indicate poorer sleep quality. A global score >5 typically indicates poor sleep quality, while a cutoff of 8 demonstrates optimal sensitivity (0.90) and specificity (0.83) for detecting sleep disturbances. The PSQI demonstrates good psychometric properties with Cronbach's alpha coefficients ranging from 0.64 to 0.89.
Measured: Baseline, 2 weeks, 6 weeks, 10 weeks
36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a measure of health-related quality of life consisting of 36 items that assess eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Items are scored using various response scales (dichotomous, 3-point, 5-point, and 6-point), with domain scores ranging from 0-100, where higher scores indicate better health status. The Cronbach's alpha of the SF-36 ranges from 0.70 to 0.94.
Measured: Baseline and 10 weeks
World Health Organization Quality of Life Assessment - Brief Version (WHOQOL-BREF)
The World Health Organization Quality of Life Assessment - Brief Version (WHOQOL-BREF) is a comprehensive 26-item self-report instrument that evaluates quality of life within the context of an individual's culture, value systems, personal goals, and standards. The scale comprises four domains: Physical Health (7 items), Psychological (6 items), Social Relationships (3 items), and Environment (8 items), plus two additional items assessing overall quality of life and general health. Each item is rated on a 5-point Likert scale, with domain scores transformed to a 0-20 scale or alternatively to a 0-100 scale for standardized comparison. The Cronbach's alpha coefficients of the WHOQOL-BREF ranges from 0.70 to 0.896.
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start27 May 2025
- Primary completion29 May 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHANG CHENCHEHG, Ruijin Hospital
- Investigators
- Yiru Fang, MD PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059143
- Sponsor's protocol ID
- 2025LLSD212-001
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Double-Blind Controlled Trial of Six-Week Transcranial Temporal Interference Stimulation(TIS) Targeting the Right Amygdala for Rapid Alleviation of Depressive Symptoms.
- ClinicalTrials.gov ID
- NCT07059143
- Acronym / sponsor ID
- 2025LLSD212-001
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Deep Brain Stimulation, Non-invasive, Amygdala, Temporal Interference, TIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 10 Jul 2025 (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, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amygdala TI | Experimental | Device: Nervio-X18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks |
| Controlled TI | Sham comparator | Device: Nervio-X18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age : 18 to 60 years (inclusive), any gender.
- Diagnosis : Major depressive episode diagnosed by study physicians according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with no restriction on first-onset or recurrent episodes.
- Symptom Severity : 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 at screening.
- Treatment Stability : Antidepressant regimen must remain unchanged from 30 days prior to signing informed consent through the study duration. Patients using >2 antidepressants or combinations of antidepressant(s) + augmenting agent(s) must be adjusted to ≤2 agents* ≥1 week prior to enrollment.
- Cognitive Capacity : Sufficient literacy and comprehension skills to complete study assessments.
Key exclusion criteria (8 listed)
- Comorbidities : Major psychiatric disorders (e.g., schizophrenia, bipolar disorder) Significant neurological conditions (e.g., traumatic brain injury, post-neurosurgical status)
- Medical Devices : Intracranial/cardiac metallic implants or electronic medical devices (e.g., pacemakers, deep brain stimulation systems)
- Recent Interventions : Electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within 30 days prior to enrollment
- Clinical Instability : Acute suicidality (e.g., active suicidal ideation with intent) Inability to complete study follow-up per investigator judgment
- Concurrent Trials : Participation in other interventional clinical studies during the trial period
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
Hamilton Depression Rating Scale (17-item version)
Time frame: Baseline, 6 weeks
The Hamilton Depression Rating Scale is a widely utilized clinician-administered instrument for assessing depression severity, consisting of 17 items that evaluate core depressive symptoms. Total scores range from 0-52, with established cutoff points: 0-7 (no depression/remission), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (severe depression), and ≥23 (very severe depression). The HAM-D17 demonstrates good internal consistency reliability with Cronbach's alpha values ranging from 0.747 to 0.829.
8 secondary outcomes
Hamilton Depression Rating Scale (17-item version)
Time frame: Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
Time frame: Baseline, 1 week, 2 weeks, 6weeks, 10 weeks
THINC-it®: An Integrated Tool for Cognitive Dysfunction Screening
Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks
Hamilton Anxiety Rating Scale (HAMA)
Time frame: Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline and 10 weeks
World Health Organization Quality of Life Assessment - Brief Version (WHOQOL-BREF)
Time frame: Baseline and 10 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 9 Jul 2026.
- 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 (MDD), 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 6 inclusion and 8 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 9 Jul 2026. 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?
Hamilton Depression Rating Scale (17-item version) (time frame: Baseline, 6 weeks). 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 9 Jul 2026.