ONE-D TMS + D-Cycloserine for Depression and Concussion

Overseen By Virginia Dykes, DAT,LAT,ATC

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: University of Florida

Must be taking: Antidepressants

Must not be taking: Ototoxic medications

Disqualifiers: Pregnancy, Seizures, Implanted devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sara Gould, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a female athlete, either recreational or professional.

Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater

I have depression that did not improve after taking an antidepressant for 6 weeks.

Exclusion Criteria

Pregnant or breast-feeding individuals

Other contraindications as determined by PI

Unable to provide informed consent due to language or other barriers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a one-day TMS treatment with pharmacologic neural priming using d-cycloserine and 20 sessions of theta-burst stimulation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with symptom inventories recorded at weeks 3, 6, and 12

12 weeks

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ONE-D TMS Treatment

How Is the Trial Designed?

Group I: Female athletes with a history of concussion and depression Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+