RecruitingNot ApplicableNCT07185438

Feasibility, Safety, and Preliminary Clinical Efficacy of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study


Sponsor

First Affiliated Hospital of Chongqing Medical University

Enrollment

45 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) intervention for adolescent depression through a pilot clinical trial. The findings will inform the design and optimization of subsequent formal randomized controlled trials, providing essential evidence for their execution.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS) — guided by MRI imaging to target the right brain areas — can help teenagers aged 12–18 with depression that hasn't improved with medication. **You may be eligible if...** - You are 12–18 years old with a current diagnosis of major depressive disorder - You have been on stable psychiatric medication for at least 4 weeks - Your depression scores on a standard scale are at or above a set threshold **You may NOT be eligible if...** - You have other psychiatric conditions besides anxiety disorders - You have symptoms of psychosis, mania, or a history of seizures or neurological disease - You have previously received brain stimulation therapy (TMS, ECT, or similar) - You have a history of alcohol or substance abuse - You are pregnant or breastfeeding - You have a high current suicide risk 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

DEVICEExperimental target rTMS treatment

Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site.

DEVICEConventional target rTMS treatment

participants will receive MRI-guided stimulation at the left DLPFC location.

DEVICESham stimulation treatment

Participants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output.


Locations(1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

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NCT07185438


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