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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Florida

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Female athletes with a history of concussion and depressionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 12 weeks
2

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.

Time frame
Baseline, 3 weeks, 6 weeks, 12 weeks

Secondary outcomes

1

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

This inventory monitors concussion symptoms

Time frame
Baseline, 12 weeks
2

Sport Concussion Office Assessment Tool 6 (SCOAT6) inventory scores

This inventory monitors post-concussion symptoms

Time frame
Baseline, 3 weeks, 6 weeks, 12 weeks

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: