RecruitingNot ApplicableNCT06452849

Amygdala and dLPFC MRI-TIS for Depression in Adolescents

Temporal Interference Stimulation of Amygdala and dLPFC: A Randomized Controlled Trial for Adolescent Depression


Sponsor

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

Enrollment

60 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a non-invasive brain stimulation technique called Temporal Interference Stimulation (TIS) — which uses mild electrical currents to activate deep brain regions — to treat depression in teenagers aged 14–18. The study targets two brain areas (the amygdala and prefrontal cortex) that are linked to mood regulation. **You may be eligible if...** - You are aged 14–18 and have been diagnosed with depression by a study doctor - Your depression is moderate to severe (HAMD-17 score of 17 or higher) - Your antidepressant medication, if any, has been stable for at least 30 days **You may NOT be eligible if...** - You have a history of epilepsy or seizures - You have metal implants in your head or a metal heart device - You have another diagnosed neurological or psychiatric condition that could affect the results - You have an organic brain disease (such as a brain tumor or stroke) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENervio-X

An 8-channel TIS device developed by NEURODOME Corporation.


Locations(1)

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, China

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NCT06452849


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