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Life sciences · Interventional Study
ClinicalTrials.gov · November 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT03986658). This is a study registration, not published results. Lead sponsor: NeuroQore Inc.. Recruitment status: WITHDRAWN. Phase: NA. Study type: INTERVENTIONAL. Conditions: Treatment Resistant Depression. Interventions: DEVICE: Linear Asymmetric rTMS System. Primary outcome measures: Patient Enrollment Rate , Through study completion, an average of 10 months; Patient Completion Rate , Through study completion, an average of 10 months; Side Effects Profile , Through study completion, an average of 10 months; Patient Experience , Through study completion, an average of 10 months. Brief summary: This is a pilot interventional study to investigate the acceptability, tolerability, and side effect profile for varying numbers of treatment sessions/day of a new rTMS treatment in adolescents with treatment-resistant depression (TRD). Conventional rTMS has been limited to sinusoidal biphasic electromagnetic pulses. In contrast, the First Dawn rTMS system by NeuroQore can sustain a repetitive linear asymmetric pulse. In addition, identification of rTMS treatment sites in adolescents with TRD most often relies on anatomic landmarks, but the First Dawn rTMS system utilizes personal fMRI data in a novel algorithm to determine where to apply the rTMS in each patient. Based on adult data in healthy volunteers and patients with TRD, the investigators propose that the First Dawn rTMS system will be acceptable and well-tolerated by adolescents and will have minimal side effects. Please see https://clinicaltrials.gov/ct2/show/NCT02667041 for details on the completed pilot study in adults. The investigators aim to investigate acceptability, tolerability, and side effects in groups of patients receiving treatment in numbers of sessions/day that are gradually accelerated over the course of the study. Results will be used to inform the development of a randomized controlled trial.