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 adolescent depressive disorders.
Participants must be aged between 14 and 18, 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 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;
Parallel
Nervio-X
DeviceAn 8-channel TIS device developed by NEURODOME Corporation.
HAMD-17
HAMA
MADRS
PHQ-A
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Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Lead sponsor
Ruijin Hospital
Collaborator
