Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
Children's Hospital Medical Center, Cincinnati
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).
Description
The overall goal of this study is to 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). Our central hypotheses are that dTMS H7 targeting the dorsomedial prefrontal and cingulate cortices, delivered via the Brainsway H7-Coil™, will be safe, well tolerated, and lead to improved depressive symptoms, reduced suicide risk, and lower readmission rates compared to sham treatment. Investigators propose a double-blind, sham-controlled randomized clinica…
Eligibility
- Age range
- 14–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Aged 14 years to 18 years, inclusive. 3. Diagnosis of MDD based on psychologist diagnosis and DSM-5-checklist based interview. 4. Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale Score \> 20. 5. Participants are not required to discontinue current interventions Exclusion Criteria: 1. Participation in an investigational drug trial within the past three months. 2…
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.
Location
- Cincinnati Childrens Hospital Medical CenterCincinnati, Ohio