Amygdala MRI-TIS for Depression

Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

Status

Enrolling

Conditions

Major Depressive Disorder

Treatments

Device: Nervio-X

Study type

Interventional

Funder types

Other

Identifiers

NCT06461260

PDJW-2024-001CSA

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

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