Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2026

Conditions
Major Depressive Disorder (MDD)Suicidal IdeationHospitalization in Children
Interventions
DEVICE

Transcranial 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 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.

DEVICE

Transcranial 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.

Trial Locations (1)

45224

RECRUITING

Cincinnati Childrens Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT07217444 - Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation | Biotech Hunter | Biotech Hunter