What this study is
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).
What's being tested
- Transcranial Magnetic Stimulation
Intervention · 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
Intervention · 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
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Major Depressive Disorder (MDD) · Suicidal Ideation · Hospitalization in Children
- Enrolling
- 60 people
- Starts
- 2025-11-13
- Est. completion
- 2026-12-30
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 14 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
- Aged 14 years to 18 years, inclusive.
- Diagnosis of MDD based on psychologist diagnosis and DSM-5-checklist based interview.
- Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale Score > 20.
- Participants are not required to discontinue current interventions
You can't join if
- Participation in an investigational drug trial within the past three months.
- Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. ventriculoperitoneal shunt, pacemaker, medical pump).
- Actively psychotic (i.e. disorganized, delusional, paranoid, or having hallucinations)
- Actively suicidal (have a suicidal plan and intent and is on 1:1 close observation)
- For female subjects of childbearing potential, a positive urine pregnancy test.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
- Ashley Krafft, Masters · Contact5138038644ashley.krafft@cchmc.org
- Jennifer Combs, Masters · Contact5138030007jennifer.combs@cchmc.org
- Rana Elmaghraby, MD · Principal investigator
Recruiting
Study team
Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID 2025-0385
Principal investigator
Rana Elmaghraby, MD
Cincinnati Childrens Hospital Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.