Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-05-27
2025-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amygdala TI
Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days.
Nervio-X
An 8-channel TIS device developed by NEURODOME Corporation.
Interventions
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Nervio-X
An 8-channel TIS device developed by NEURODOME Corporation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
OTHER
Responsible Party
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Jingjing Huang, MD
Chief Physician
Locations
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Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jingjing Huang
Role: primary
Other Identifiers
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PDJW-2024-001CSA
Identifier Type: -
Identifier Source: org_study_id
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