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

NCT07507214 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: IRB202600155
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion; Depression

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire 9 (PHQ-9) depression symptom inventory scores

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

  Baseline, 12 weeks

• Sport Mental Health Assessment Tool 1 (SMHAT-1) depression symptom inventory scores

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

  Baseline, 3 weeks, 6 weeks, 12 weeks

Secondary Outcomes (2)

• Post-Concussion Symptom Scale (PCSS) inventory of concussion symptoms

  Baseline, 12 weeks

• Sport Concussion Office Assessment Tool 6 (SCOAT6) inventory scores

  Baseline, 3 weeks, 6 weeks, 12 weeks

Study Arms (1)

Female athletes with a history of concussion and depression

EXPERIMENTAL

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).

Device: ONE-D TMS protocol and d-cycloserine (125 mg)

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).

Female athletes with a history of concussion and depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF World Equestrian Center

Ocala, Florida, 34482, United States

Location

MeSH Terms

Conditions

Brain Concussion; Depression

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavioral Symptoms; Behavior

Study Officials

• Sara Gould, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Gould, MD

CONTACT

352-273-7381; gouldsj@ortho.ufl.edu

Virginia Dykes, DAT,LAT,ATC

CONTACT

352-273-7343; jacksve@ortho.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)