ONE-D TMS Treatment for Depression in Female Athletes with Concussion

ClinicalTrials.gov published registration NCT07507214 for an observational/therapeutic study investigating ONE-D TMS treatment for depression in female athletes who have a history of concussion. The study targets female athletes aged 18-35 years old and will evaluate the effectiveness of TMS intervention on reducing depressive symptoms. The study is registered as an interventional trial, likely with potential FDA device regulation implications for TMS equipment.

Compliance officers and research coordinators reviewing this registration should note this represents an active clinical investigation in the neuromodulation/depression space. No immediate compliance action is required for this registration document. Research institutions or sponsors involved in similar TMS or concussion-related depression studies should ensure their own trials are properly registered and that any applicable FDA IDE requirements are met for significant risk device studies.