The Role of Hypoxia on Subconcussive Head Impacts

NCT04624152 | Completed

• 1 other identifier: 1806106387
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Brain

Keywords

soccer heading; subconcussive head impacts; hypoxia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Change in neurocognitive function at 24 hours post-heading follow-up

  Neurocognitive function will also assessed at 24 hours post-heading

• Change in ocular-motor function at 24 hours post-heading follow-up

  Ocular-motor function will also assessed at 24 hours post-heading

• Change in brain-derived blood biomarkers at 24 hours post-heading follow-up

  A third blood sample will be collected at 24 hours post-heading

• Acute change in saccadic eye movement function from pre-heading at 0 and 24 hour post-heading

  Saccadic eye movement function will be assessed at pre- , 0, and 24 hour post-heading

• Acute change in smooth eye pursuit function from pre-heading at 0 and 24 hour post-heading

  Smooth eye pursuit function will be assessed at pre- , 0, and 24 hour post-heading

Study Arms (2)

Normobaric Hypoxia

EXPERIMENTAL

Large weather balloons will be filled with a normobaric hypoxic inspirate (FiO2 = 0.15) produced by a nitrogen generator (CAT 12; Colorado Altitude Training, Boulder, CO) to simulate an altitude of 2600 m (8500 ft). Participants breathed this inspirate through a two-way non-rebreathing valve (2700; Hans Rudolph, Kansas City, KS) and an oronasal mask (7450 V2; Hans Rudolph, Kansas City, KS). Participants breathed this inspirate from 15 minutes before the pre-heading time point until the conclusion of the 0h post-heading time point.

Behavioral: Soccer heading

Normobaric Normoxia

PLACEBO COMPARATOR

Large weather balloons will be filled with room air (FiO2 = 0.21). Participants breathed this normobaric normoxic inspirate through a two-way non-rebreathing valve (2700; Hans Rudolph, Kansas City, KS) and an oronasal mask (7450 V2; Hans Rudolph, Kansas City, KS). Participants breathed this inspirate from 15 minutes before the pre-heading time point until the conclusion of the 0h post-heading time point.

Behavioral: Soccer heading

Interventions

Soccer heading BEHAVIORAL

A standardized and reliable soccer heading protocol will be used to induce subconcussive impacts for the experiment. A triaxial accelerometer (Triax Technologies, Norwalk, CT) embedded in a head-band pocket and positioned back of the head to monitor linear and rotational head accelerations. A JUGS soccer machine (JUGS Sports, Tualatin, OR) will be used to simulate a soccer throw-in with a standardized ball speed of 25 mph across all groups. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practices and games. Participants will stand approximately 40ft away from the machine to perform the heading. Participants will perform a total of 10 headers at a rate of 1 header per minute and will be instructed to direct the ball back towards the JUGS machine. Previous uses of this soccer heading model have reported an average peak linear acceleration per header of 14.5 to 33.5 g.

Normobaric Hypoxia; Normobaric Normoxia

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: As a part of the neurocognitive assessment, participants self-select one of the gender options from a list.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hypoxia

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Kinesiology

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: October 22, 2018
• Primary Completion: April 2, 2019
• Study Completion: May 1, 2019
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

US (1)