About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Nervio-X
Treatment groups
Sponsors and collaborators
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Lead sponsor
Ruijin Hospital
Collaborator