Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07217444
Status
Recruiting
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Conditions

  • Hospitalization in Children
  • Major Depressive Disorder (MDD)
  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
14 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation — DEVICE
    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.
  • Transcranial Magnetic Stimulation Sham — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Nov 13, 2025
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active dTMS Treatment
    Participants will receive active dTMS 5 sessions per day for 5 days
  • Sham Comparator: Sham controlled
    Sham dTMS 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12th month follow-up -reduction in depression symptoms from screening - they will then become eligible for and offered active, open-label treatment.

Primary Outcome Measure

Tolerability and Safety [ Time Frame: Completed before and immediately after the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45224
Ashley Krafft, Masters
[email protected]
5138038644
Jennifer Combs, Masters
[email protected]
5138030007
Rana Elmaghraby, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cincinnati Childrens Hospital Medical Center· Cincinnati, OH

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