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NCT07507214 · ClinicalTrials.gov registry record · Phase 2
Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion
A Phase 2 study, sponsored by University of Florida.
- Not yet
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT07507214: Clinical Trial Phase 2 study, sponsored by University of Florida.
NCT07507214 is a Phase 2 study that has not yet begun recruiting, run by University of Florida. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07507214, a Phase 2 study, has not yet begun recruiting, sponsored by University of Florida.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
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.
Primary Outcome
These inventories track not only mental health symptoms, but also somatic symptoms that can be affected by depression, including sleep and athletic performance.
Interventions
- DEVICE ONE-D TMS protocol and d-cycloserine (125 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 2 |
What is known before NCT07507214 opens enrollment
NCT07507214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which ONE-D TMS protocol and d-cycloserine (125 mg) is the first listed.
NCT07507214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07507214 about?
NCT07507214 is a clinical study titled "Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion". 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...
What is the current status of trial NCT07507214?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2026-06-01. Estimated completion is 2028-06-01.
What interventions are being tested in trial NCT07507214?
The interventions under investigation include: ONE-D TMS protocol and d-cycloserine (125 mg) (DEVICE).
Who is sponsoring clinical trial NCT07507214?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07507214's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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