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 volunteersQualifiers
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
Single group
Treatments tested in this trial
ONE-D TMS protocol and d-cycloserine (125 mg)
DeviceBegin 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
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Post-Concussion Symptom Scale (PCSS) inventory of concussion symptoms
This inventory monitors concussion symptoms
Sport Concussion Office Assessment Tool 6 (SCOAT6) inventory scores
This inventory monitors post-concussion symptoms
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: