Amygdala and dLPFC MRI-TIS for Depression in Adolescents

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorShanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

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

60 Participants
are divided into 2 treatment groups