Trauma, BrainNCT04624152
The Role of Hypoxia on Subconcussive Head Impacts
A study testing Soccer heading in people with Trauma, Brain, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Brain
- What is being tested?
- Soccer heading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combined Effects of Hypoxia and Subconcussive Head Impacts on Neurocognitive Function: a Pilot Randomized Crossover Study
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.
Read the 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.
- Conditions
- Trauma, Brain
- Being tested
- Soccer heading
- Keywords
- soccer heading, subconcussive head impacts, hypoxia
- Medical subject headings
- Brain Injuries, Traumatic, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soccer headingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Soccer heading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Upon their return to the laboratory, participants will again complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Measured: Neurocognitive function will also assessed at 24 hours post-heading
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.
Measured: Ocular-motor function will also assessed at 24 hours post-heading
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.
Measured: 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
Participants will undergo King-Devick Test--a brief assessment of saccadic eye movements, attention, and visual and language processing
Measured: 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
Participants will undergo the EYE-SYNC smooth pursuit task.
Measured: Smooth eye pursuit function will be assessed at pre- , 0, and 24 hour post-heading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start22 Oct 2018
- Primary completion2 Apr 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, BrainStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keisuke Kawata, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624152
- Sponsor's protocol ID
- 1806106387
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effects of Hypoxia and Subconcussive Head Impacts on Neurocognitive Function: a Pilot Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT04624152
- Acronym / sponsor ID
- 1806106387
- Conditions
- Trauma, Brain
- Keywords
- soccer heading, subconcussive head impacts, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normobaric Hypoxia | Experimental | Behavioral: Soccer headingLarge 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. |
| Normobaric Normoxia | Placebo comparator | Behavioral: Soccer headingLarge 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soccer headingA 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. | Behavioural | Normobaric Hypoxia, Normobaric Normoxia |
Primary outcome
Acute change in neurocognitive function from pre-heading at 0 hour post-heading
Time frame: Neurocognitive function will be assessed at pre- and 0 hour post-heading
Participants will complete a computerized neurocognitive assessment (Immediate Post-Concussion Assessment and Cognitive Testing).
Acute change in convergence function from pre-heading at 0 hour post-heading
Time frame: Conversion function will be assessed at pre- and 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.
Acute change in brain-derived blood biomarkers from pre-heading at 0 hour post-heading
Time frame: Blood samples will be collected at pre- and 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.
5 secondary outcomes
Change in neurocognitive function at 24 hours post-heading follow-up
Time frame: Neurocognitive function will also assessed at 24 hours post-heading
Change in ocular-motor function at 24 hours post-heading follow-up
Time frame: Ocular-motor function will also assessed at 24 hours post-heading
Change in brain-derived blood biomarkers at 24 hours post-heading follow-up
Time frame: 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
Time frame: 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
Time frame: Smooth eye pursuit function will be assessed at pre- , 0, and 24 hour post-heading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soccer heading in people with Trauma, Brain, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change in neurocognitive function from pre-heading at 0 hour post-heading (time frame: Neurocognitive function will be assessed at pre- and 0 hour post-heading). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.