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

Part of paid clinical trials in Ocala, Florida.

Sponsor
University of Florida
Study ID
NCT07507214
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ONE-D TMS protocol and d-cycloserine (125 mg) — DEVICE
    Begin the ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).

Study Details

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 Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Female athletes with a history of concussion and depression
    Participants are treated with ONE-D TMS protocol.9 The protocol consists of pharmacologic neural priming via a single dose of orally dissolving d-cycloserine (125 mg).

Primary Outcome Measure

Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scores [ Time Frame: Baseline, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF World Equestrian CenterOcalaFlorida34482
Sara Gould, MD
[email protected]
352-273-7381
Virginia Dykes, DAT,LAT,ATC
[email protected]
352-273-7343

Find similar trials in Ocala, FL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
UF World Equestrian Center· Ocala, FL

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