Trauma, Brain Clinical Trial
Official title:
The Combined Effects of Hypoxia and Subconcussive Head Impacts on Neurocognitive Function: a Pilot Randomized Crossover Study
NCT number | NCT04624152 |
Other study ID # | 1806106387 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 22, 2018 |
Est. completion date | May 1, 2019 |
Verified date | November 2020 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the combined effects of hypoxia and a short bout of subconcussive head impacts on neurocognitive and ocular-motor function and plasma expression of brain-derived blood biomarkers.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 1, 2019 |
Est. primary completion date | April 2, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 26 Years |
Eligibility | Inclusion Criteria: - Between 18 and 26 years old - Current or former soccer player (i.e., collegiate, intramural, club, professional) - At least 3 years of soccer heading experience - Participants can read and speak English - Participants have cell phone or computer with internet access to schedule for follow-up visits via email or text message - Participant is willing to refrain from participating in any sport activity that purposefully uses one's head to maneuver (American football, ice-hockey, rugby, wrestling, and soccer heading) during study participation Exclusion Criteria: - Any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury) - History of vestibular, ocular, or vision dysfunction (e.g., macular degeneration) - Currently taking any medications that trigger drowsiness - Pregnancy - Any history of neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, spinal cord injury/surgery, history of stroke) - Lower extremity injury that would prohibit normal walking - Metal implants in the head Conditional Exclusion Criteria Based on participants' self report: those who meet any of the following criteria, he/she will be either excluded or rescheduled (if they still wish to participate in the study): - Slept less than 4 hours during the night prior to the testing day - Consumed more than 3 alcoholic drinks within 24h prior to testing - Used recreational drugs 24h prior to the testing day - Consumed more than 300 mg of caffeine (the equivalent of about 3 cups of coffee) within 1h before testing sessions |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Bloomington | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute change in neurocognitive function from pre-heading at 0 hour post-heading | Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing). | Neurocognitive function will be assessed at pre- and 0 hour post-heading | |
Primary | Acute change in convergence function from pre-heading at 0 hour post-heading | Participants will undergo near-point of convergence (in centimeter) to evaluate how closely one can visualize a moving target without double vision occurs. | Conversion function will be assessed at pre- and 0 hour post-heading | |
Primary | Acute change in brain-derived blood biomarkers from pre-heading at 0 hour post-heading | Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Plasma will be aliquoted and stored at -80 degree celsius until analysis.
Plasma samples will be assayed for neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau. |
Blood samples will be collected at pre- and 0 hour post-heading | |
Secondary | Change in neurocognitive function at 24 hours post-heading follow-up | Upon their return to the laboratory, participants will again complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing). | Neurocognitive function will also assessed at 24 hours post-heading | |
Secondary | Change in ocular-motor function at 24 hours post-heading follow-up | Upon their return to the laboratory, participants will again undergo three ocular-motor assessments: 1) near-point of convergence; 2) King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing; and 3) the EYE-SYNC smooth pursuit task. | Ocular-motor function will also assessed at 24 hours post-heading | |
Secondary | Change in brain-derived blood biomarkers at 24 hours post-heading follow-up | Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Plasma will be aliquoted and stored at -80 degree celsius until analysis.
Plasma samples will be assayed for neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), and tau. |
A third blood sample will be collected at 24 hours post-heading | |
Secondary | Acute change in saccadic eye movement function from pre-heading at 0 and 24 hour post-heading | Participants will undergo King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing | Saccadic eye movement function will be assessed at pre- , 0, and 24 hour post-heading | |
Secondary | Acute change in smooth eye pursuit function from pre-heading at 0 and 24 hour post-heading | Participants will undergo the EYE-SYNC smooth pursuit task. | Smooth eye pursuit function will be assessed at pre- , 0, and 24 hour post-heading |
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