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| ID | Type | Description | Link |
|---|---|---|---|
| US Department of Defense | Other Grant/Funding Number | US Department of Defense |
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The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.
Up to 350 total collegiate athletes and athlete-cadets will be enrolled. Approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the Observational arm; approximately half the participants will be female.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (Ad-Lib Exercise) Arm | No Intervention | All participants will undergo neurologic outcome testing with optical coherence tomography/angiography (OCT/A) at pre- and post-season and 2 weeks after the end of the season. For two weeks at the end of the sport season, participants will be instructed to refrain from sports involving head contact but to otherwise exercise ad-lib. | |
| Intervention (Exercise or Stretching) Arm | Experimental | Athletes and athlete cadets will be administered OCT/A and a novel neurologic test battery at pre- and post-season, and 2 weeks after the end of the season. After the end-of-season assessments, participants will be randomized to 2 weeks of either 30 minutes of daily aerobic exercise or to 30-minutes of prescribed stretching. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise | Other | After the end-of-season assessments, participants in the Intervention (Exercise or Stretching) arm will be randomized to 2 weeks of daily aerobic exercise for 30 minutes or to 30-minutes of prescribed stretching. |
| Measure | Description | Time Frame |
|---|---|---|
| Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina) | A primary OCT variables examined will be macula cerebrospinal fluid (CSF) thickness (an indicator of the gain or loss of neurons or glia in the inner nuclear, ganglion cell and nerve fiber layer). | Pre-season and post-season, 2 weeks |
| Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP) | Glial Fibrillary Acidic Protein (GFAP) concentration will determine if there is a 11.9 pg/mL or greater change in GFAP in each participant over the course of the study. | Baseline 4 to 7 months |
| Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample | The neurologic test battery consists of blood draws for serum brain proteins: Neurofilament light chain (NfL) concentrations will be observed for changes over the course of the study. | Baseline 4 to 7 months |
| Change in p-231Tau serum concentration in a blood sample | The neurologic test battery consists of blood draws for serum brain proteins: p231Tau will be observed for changes over the course of the study. | Baseline 4 to 7 months |
| Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG) | The Quantitative Electroencephalogram (qEEG) Concussion Index (CI) includes measures of power (absolute and relative), mean frequency, connectivity (asymmetry, coherence, phase lag, phase synchrony), complexity (fractal dimension and scale-free activity), and information theory (entropy), across and within frequency bands. | Baseline 4 to 7 months |
| Change in near-point convergence (NPC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Amherst | New York | 14221 | United States | ||
| University of Rochester |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Near point of convergence (NPC) is a measurement of how close an object can be brought to the eyes while the eyes are focused on it. |
| Baseline 4 to 7 months |
| Change in Choice reaction time (CRT) | Choice reaction time (CRT) refers to the time it takes for a person to react to a stimulus by selecting a specific response from multiple options. | Baseline 4 to 7 months |
| Change in blink reflex test | A blink reflex test, also known as a corneal reflex test, is a non-invasive procedure that measures the electrical activity of the facial nerves when stimulated. | Baseline 4 to 7 months |
| Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina | OCT will be used to measure the cup-to-disc ratio of the optic disc, and indicator of neurodegeneration. | Pre-season and post-season, 2 weeks |
| Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retina | Retinal vascular structure will be acquired using the OCT angiography (OCT/A). The primary OCT/A variable examined will be foveal avascular zone (FAZ) area reflecting the size of the central portion of the macula which contains no blood vessels, and which increases in size with loss of capillaries in the surrounding region). | Pre-season and post-season, 2 weeks |
| Rochester |
| New York |
| 14620 |
| United States |
| The Citadel, The Military College of South Carolina | Charleston | South Carolina | 29409 | United States |