Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion
Starting soon · Phase 2/Phase 3
Conditions studied: Concussion, Depression
In brief
Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits: Previous studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.
Key facts
- Study ID
- NCT07507214
- Run by
- University of Florida
- People needed
- 35
- Starts
- 2026-06-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female athletes, both recreational and professional
- ages 18-65 years old
- Concussion as determined by clinical history (at least 72 hours post-diagnosis) and Post-Concussion Symptom Scale (PCSS) score above 7 OR more than 4 total symptoms present
- Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater
- Treatment-resistant depression as determined by previously taken or currently taking an oral antidepressant for at least 6 weeks
You may not qualify if…
- Pregnant or breast-feeding individuals
- History of seizures or epilepsy
- Implanted devices (such as cochlear implants, brain stimulators, aneurysm clips or stents)
- Participants undergoing treatment with ototoxic medications (aminoglycosides, cisplatin)
- History of bipolar disorder
- Pacemakers or implanted defibrillators
- Allergy or other contraindications to d-cycloserine
- Other contraindications as determined by PI
- Unable to provide informed consent due to language or other barriers
- Incarceration
- Biological male gender
Where it is running
- UF World Equestrian Center — Ocala, Florida, United States
Full record on ClinicalTrials.gov
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