RecruitingNCT06461260Updated Jun 14, 2024

Amygdala MRI-TIS for Depression

An interventional study of Nervio-X in Major Depressive Disorder, sponsored by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
Started May 2024; still recruiting 2 years 4 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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 basis for the application of TI technology.

Conditions studied

Major Depressive Disorder

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Keywords

Major Depressive Disorder
Deep Brain Stimulation
TI stimulation

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 30 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;
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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
Amygdala TI
Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days.
Device: Nervio-X

Interventions

DeviceNervio-X
An 8-channel TIS device developed by NEURODOME Corporation.

What researchers measure

Primary outcomes

HAMD-17
Time frame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks

Secondary outcomes

HAMA
HAMA is a questionnaire that designed to evaluate the presence and intensity of anxiety symptoms in both clinical and research settings.
Time frame: 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.
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®
THINC-it® is a screening tool for assessment of cognitive functioning in patients with a major depressive episode/disorder
Time frame: 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
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

Study locations

1 of 1 sites recruiting

Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai, China
- Jingjing Huang · Contact · 021-68306699*1222
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06461260
Lead sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Collaborators: Ruijin Hospital
Responsible party: Jingjing Huang, MD (Chief Physician, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University) — Principal investigator
First posted: Jun 14, 2024
Start date: May 27, 2024
Primary completion: Apr 28, 2025 (estimated)
Completion: Apr 28, 2025 (estimated)
Last update: Jun 14, 2024

Study contacts

Jingjing HUANG, MD PhD

Contact

jjhuang_att@163.com

021-68306699*1222

Chencheng Zhang, MD PhD

Contact

i@cczhang.org

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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