Deep Transcranial Magnetic Stimulation for Adolescent Inpatient Depression
This study is looking at a treatment called deep Transcranial Magnetic Stimulation (dTMS) using the Brainsway Deep TMS System with the H7 Coil. It's for adolescents aged 14 to 18 who are in the hospital for Major Depressive Disorder (MDD) and may have suicidal thoughts. The study wants to see if dTMS is safe, well-tolerated, and helps improve depression symptoms and reduce the risk of suicide and re-hospitalization. Some participants will receive the actual dTMS treatment, while others will receive a sham treatment that feels similar but doesn't deliver the magnetic stimulation. The main goals are to check the safety and how well participants tolerate the treatment. The study plans to enroll 60 participants.
- Study design
- This is a double-blind, sham-controlled randomized clinical trial, meaning neither you nor the study team will know if you are receiving the active dTMS or the sham treatment. It aims to enroll 60 participants.
- What's involved
- Participants will receive either active or sham dTMS during their hospitalization. Follow-up assessments will continue for 12 months after discharge.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after they leave the hospital.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rana Elmaghraby, MD · PRINCIPAL_INVESTIGATOR · Cincinnati Childrens Hospital Medical Center
Who to contact
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What this trial measures
- Tolerability and SafetyCompleted before and immediately after the intervention
We will collect and summarize descriptive data on discomfort and adverse events using Sections IV of the TMS Adverse Events and Associated Sensations Questionnaire (TMSens\_Q). This captures typical sensory experiences or side effects, e.g. scalp tingling or headache) as well as adverse events (e.g. syncope). Tolerability will be characterized based on sensory experiences and side effects, comparing active to sham treatment. Safety will be further assessed by the rate of early discontinuation due to intolerability or adverse events using the CCHMC Adverse Event form. Tolerability: Unit of measure: frequency and severity of sensory experiences and adverse events, e.g. scalp tingling or headache, syncope). Safety: Unit of measure: Rate of early discontinuation or withdrawal of treatment due to intolerability or adverse events.