RecruitingNot ApplicableNCT07217444

Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

60 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

Suicidal Ideation Major Depressive Disorder (MDD)Hospitalization in Children

Summary

Evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD).

Eligibility

Min Age: 14 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain stimulation therapy called deep transcranial magnetic stimulation (TMS) for teenagers who are hospitalized for severe depression. TMS uses magnetic pulses to gently stimulate areas of the brain involved in mood, and it is already used in adults with depression. **You may be eligible if...** - You are between 14 and 18 years old - You have been diagnosed with moderate-to-severe Major Depressive Disorder (MDD) - You are currently an inpatient (hospitalized) for depression treatment - You are fluent in English - You can participate in the consent process and understand the study **You may NOT be eligible if...** - You have a history of epilepsy (seizures) or have metal implants in your head (e.g., ventriculoperitoneal shunt, pacemaker) - You are currently experiencing psychosis (hallucinations, delusions) - You are actively suicidal with a plan and intent, and under one-to-one observation - You are pregnant (for female participants of childbearing age) - You participated in another investigational drug trial in the past 3 months 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

DEVICETranscranial Magnetic Stimulation

The Brainsway Deep TMS System with the FDA-cleared H7 Coil will be used to deliver all accelerated theta burst stimulation (aTBS) sessions. The H7 Coil is designed to target deeper and broader brain regions, including the prefrontal and anterior cingulate cortices, and has FDA 510(k) clearance for treatment of OCD and MDD in adults. Stimulation will follow a standardized accelerated theta burst protocol: triplet 50 Hz bursts delivered every 200 ms (5 Hz), in 2-second trains with 8 seconds off, at 90% RMT, totaling 600 pulses per session. Participants will receive five sessions per day over five business days with 30-minute breaks between the third and fourth sessions and exceeding or preceding these breaks will not be a protocol deviation. The sham coil mimics sensory experience without delivering stimulation.

DEVICETranscranial Magnetic Stimulation Sham

Investigators will use a robust sham technique that is manufacturer-designed to mimic the auditory and tactile sensations of active TMS without delivering effective magnetic stimulation to the brain. The Brainsway Sham H7-CoilTM will be utilized for treatment delivery. The H-7 coil already has a built-in sham system that can operate as a placebo. Only the TMS operators will have access to intervention assignments, the rest of the study team will not have access to assignments to maintain the blinded status of participants, caregivers, and raters.