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

This study is exploring a new treatment for female athletes who have both a concussion and depression. It tests a special type of transcranial magnetic stimulation (TMS) called the Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) protocol. This TMS treatment is given along with a single dose of d-cycloserine (125 mg), a medication that helps with brain plasticity. The study aims to see if this treatment can improve symptoms of depression. Researchers will measure depression symptoms using questionnaires like the Patient Health Questionnaire 9 (PHQ-9) and the Sport Mental Health Assessment Tool 1 (SMHAT-1) at different times over 12 weeks. You may be able to join if you are a female athlete between 18 and 65 years old, have had a concussion, and have moderate depression. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 35 female participants. It tests a specific treatment protocol for concussion and depression.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' depression symptoms will be monitored for 12 weeks after the treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07507214

Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion

Not Yet Recruiting
PHASE2Ages 18–65InterventionalTreatment
University of Florida
~35 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:ONE-D TMS protocol and d-cycloserine (125 mg)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scores
Measured over Baseline, 12 weeks
+1 more outcome measured

Conditions

Concussion
Depression

Explore related trials

ConcussionDepression

NCT07507214

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UF World Equestrian Center

    Ocala, Floridastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sara Gould, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Sara Gould, MD
[email protected]
352-273-7381
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scoresBaseline, 12 weeks

    These inventories track not only mental health symptoms, but also somatic symptoms that can be affected by depression, including sleep and athletic performance.

  • Sport Mental Health Assessment Tool 1 (SMHAT-1) depression symptom inventory scoresBaseline, 3 weeks, 6 weeks, 12 weeks

    These inventories track not only mental health symptoms, but also somatic symptoms that can be affected by depression, including sleep and athletic performance.