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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.
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.
The objective of this application is to treat female athletes with depression and concussion with the Optimized, Neuroplasticity-Enhanced techniques in Depression (ONE-D) protocol.7 This is an innovative, one-day duration TMS treatment for depression. We propose to utilize tradition depression assessments, such as the Patient Health Questionnaire 9 (PHQ-9)8, as well as athlete-specific symptom inventories, including the Post-Concussion Symptom Scale (PCSS)9 and the Sport Mental Health Assessment Tool 1 (SMHAT-1)10 surveys to test our central hypothesis that female athletes with a history of concussion and depression will experience symptom improvement in depression inventories as well as athlete-specific symptom domains. We will assess associations between TMS treatment and depression through PHQ-9 and SMHAT-1 and associations between TMS treatment and concussion symptoms through PCSS.
Treatment Delivery
Once the subject completes the consent process, they will 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).The UF-World Equestrian center (WEC) pharmacy will dispense this medication prior to the study visit. The WEC pharmacy is located in the same physical building as the clinic where the treatment will take place. Patients will obtain their medication from the pharmacy prior to their treatment appointment. The medications will be consumed one hour (50-70 min) prior to the start of the first treatment under study staff supervision. After consuming the medication, the participant will begin baseline symptom inventory scores, including Sport Concussion Office Assessment Tool 6 (SCOAT6), Post-Concussion Symptom Scale (PCSS), Patient Health Questionnaire 9 (PHQ-9) and the Sport Mental Health Assessment Tool 1 (SMHAT-1).18 The treatment protocol consists of an AMPA device delivering accelerate theta-burst stimulation for a total of 600 pulses over 3 minute sessions.9 The treatment is repeated every 30 minutes (± 3 min) for a total of 20 sessions over 9.5 hours in a single day. The treatment will be performed by the research assistant or the research coordinator under PI supervision.
The Ampa TMS system was selected for this study as it uses anatomic locations to guide treatment targets, as opposed to other commercially available TMS systems that require FMRI imaging to create individual treatment plans. AMPS technology is FDA approved to be utilized in this manner.
Treatment parameters:
Symptom inventories will be recorded at weeks 3, 6, and 12 after the treatment session. The surveys will be collected through Redcap. Due to the nature of the surveys, the subjects will be called by a member of the research team during business hours so that if any subject is deemed positive for suicidality, the research team can immediately contact the PI and refer patient to treatment as stated in DSMB/DSMP. This may include a 911 welfare check. At the 12-week mark, the subjects will be called via zoom video call to complete the SCOAT6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Concussion Symptom Scale (PCSS) inventory of concussion symptoms | This inventory monitors concussion symptoms | Baseline, 12 weeks |
| Sport Concussion Office Assessment Tool 6 (SCOAT6) inventory scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Gould, MD | Contact | 352-273-7381 | gouldsj@ortho.ufl.edu | |
| Virginia Dykes, DAT,LAT,ATC | Contact | 352-273-7343 | jacksve@ortho.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sara Gould, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF World Equestrian Center | Ocala | Florida | 34482 | United States |
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This inventory monitors post-concussion symptoms
| Baseline, 3 weeks, 6 weeks, 12 weeks |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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