Clinical trial NCT04624152: The Role of Hypoxia on Subconcussive Head Impacts
Official title: The Combined Effects of Hypoxia and Subconcussive Head Impacts on Neurocognitive Function: a Pilot Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma, Brain
Keywords: soccer heading
subconcussive head impacts
hypoxia
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The purpose of the pilot study is to observe preliminary trends in neural response to subconcussive head impacts in hypoxic condition. This work will provide a critical un-tested knowledge regarding the combined effects of subconcussion and hypoxic condition (mimicking high altitude), which will be used in our upcoming grant proposal to the Department of Defense (DoD). Military personnel, particularly those who are deployed to Afghanistan, are constantly subjected to hypoxic condition, given that the majority of military land operations in Afghanistan occur at 2000-3000 meters (6500-10,000 feet). This level of altitude does not elicit major side effects, yet neural functions may experience some degree of perturbation (i.e., slowed reaction time, altered night vision). Concurrently, these military personnel, who operate at high altitudes, often incur subconcussive forces to the head. These subconcussive head impacts can be induced by exposure to, for example, flash-bang grenades, artillery fire, recoilless rifle, improvised explosive devices (IEDs), and head collision. The combined effects of these two stressors have the potential to attenuate one's readiness, operational efficiency, and overall brain function, but the combined effects have never been studied to date. As a result, one of four study topics that the Defense Centers of Excellence deems urgent is: Document the effects of altitude exposure on mild traumatic brain injury (mTBI) and blast-induced neurotrauma (BINT). To answer the question, we hypothesized that there will be an exponential worsening in neurocognitive function and in ocular-motor system functioning, and increased plasma expression of brain-derived biomarkers, after subconcussive head impacts under hypoxic conditions.

Eligibility criteria: 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

Primary outcomes:
measure: Acute change in neurocognitive function from pre-heading at 0 hour post-heading
timeFrame: Neurocognitive function will be assessed at pre- and 0 hour post-heading
measure: Acute change in convergence function from pre-heading at 0 hour post-heading
timeFrame: Conversion function will be assessed at pre- and 0 hour post-heading
measure: Acute change in brain-derived blood biomarkers from pre-heading at 0 hour post-heading
timeFrame: Blood samples will be collected at pre- and 0 hour post-heading
Secondary outcomes:
measure: Change in neurocognitive function at 24 hours post-heading follow-up
timeFrame: Neurocognitive function will also assessed at 24 hours post-heading
measure: Change in ocular-motor function at 24 hours post-heading follow-up
timeFrame: Ocular-motor function will also assessed at 24 hours post-heading
measure: Change in brain-derived blood biomarkers at 24 hours post-heading follow-up
timeFrame: A third blood sample will be collected at 24 hours post-heading
measure: Acute change in saccadic eye movement function from pre-heading at 0 and 24 hour post-heading
timeFrame: Saccadic eye movement function will be assessed at pre- , 0, and 24 hour post-heading
measure: Acute change in smooth eye pursuit function from pre-heading at 0 and 24 hour post-heading
timeFrame: Smooth eye pursuit function will be assessed at pre- , 0, and 24 hour post-heading
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
References: