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Recruiting NCT06452849

Amygdala and dLPFC MRI-TIS for Depression in Adolescents

Trial Parameters

Condition Major Depressive Disorder
Sponsor Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 14 Years
Max Age 18 Years
Start Date 2024-05-27
Completion 2025-04-28
Interventions
Nervio-X

Brief Summary

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

Inclusion Criteria: * 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 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 seizure

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