RHI Interval Effects on Brain Health
ConditionRepetitive Head Impacts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorIndiana University
About this trial
Military service members frequently experience repetitive insults or impacts to the head (RHIs). The purpose of the proposed randomized controlled trial is to understand how time intervals affect neurological responses to repetitive subconcussive head impacts.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Current soccer player (intercollegiate, club, intramural, recreational).
At least 5 years of soccer heading experience (justification below).
Ability to provide informed consent without a legally authorized representative (LAR).
Disqualifiers
Any head, neck, or face injury within the 6 months prior to enrollment, including concussions, that precludes participation in contact sports.
Participants with eye conditions or diseases that could impact the blood vessels in the eye -such as but not limited to: glaucoma, macular degeneration, diabetic retinopathy.
Determination that the participant is unsuitable for study entry or potentially unable to complete all aspects of the study based on the judgement of the Investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Short Interval
Other interventionA standardized and reliable soccer heading protocol will be used for the experiment. Participants perform 16 headers or kicking with 1 header per 30 seconds. The sessions (twice per week for 4 weeks) will be separated by 24 hours.
Long Interval
Other interventionA standardized and reliable soccer heading protocol will be used for the experiment. Participants perform 16 headers or kicking with 1 header per 30 seconds. The sessions (twice per week for 4 weeks) will be separated by 72 hours.
BrainScope qEEG
DeviceAn Investigational version of the BrainScope FDA-cleared qEEG acquisition device will be used in this study. The investigational nature of the device is simply based on the code which does not produce a diagnostic result for the blinded researcher. Electrodes will be placed around the participant's forehead and scalp to acquire electrical readings of brain activity.
Treatment groups
102 Participants
are divided into 4 treatment groupsGroup A: Short Interval - headingExperimental treatment 2 interventions
Group B: Long Interval - headingExperimental treatment 2 interventions
Group C: Short Interval - kickingSham comparator 2 interventions
Group D: Long Interval - kickingSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Blood Biomarkers - NfL
The primary outcome analyses will be comparing group differences (group x time interactions) in blood biomarkers, specifically NF-L (neurofilament light).
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading session2
Blood Biomarkers - GFAP
The primary outcome analyses will be comparing group differences (group x time interactions) in blood biomarkers, specifically GFAP (glial fibrillary acidic protein; nanograms per milliliter).
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading session3
Blood Biomarkers - pTau
The primary outcome analyses will be comparing group differences (group x time interactions) in blood biomarkers, specifically phosphorylated tau (picogram per milliliter).
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading session4
Optical Coherence Tomography/Angiography (OCT/A) 1
Retinal neural structure will be imaged in one or both eyes using high-definition spectral domain OCT, which will be acquired using a Zeiss Cirrus OCT scanner. The primary OCT variables examined will be macula CSF thickness (an indicator of the gain or loss of neurons or glia in the inner nuclear, ganglion cell and nerve fiber layer). Retinal vascular structure will be acquired using the OCT angiography (OCT/A) capability of the Cirrus.
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading sessionSecondary outcomes
1
Near Point of Convergence (NPC)
NPC will also be assessed on the BrainScope qEEG device. The automatic NPC measurement is administered in the same manner as the manual NPC test and takes less than a minute to perform. The participant focuses on the target at arm's length and slowly brings it toward the tip of their nose. The participant is instructed to stop moving the target when they see two distinct images or when the examiner observes an outward deviation of one eye. Blurring of the image is ignored. The distance between the target and the tip of the participant's nose is recorded in centimeters (cm), digitally and accurately computed by the BrainScope automated ocular function measurement (AOFM) feature.
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading session2
Pupillary Size Measurement and Reactivity 1
Pupillary Size Measurement and reactivity will be measured in one or both eyes using the NeurOptics PLR-4000 pupillometer device. The eye cup of the hand-held optical scanner system is placed over the participant's eye at a right angle to their axis of vision while the user uses a touchscreen to center the participant's pupil. Once centered, the user initiates the protocol by push-button, and light pulses of 121 uW intensity and 0.80 s duration are used to stimulate pupil reflex and dilation over approximately 6 seconds. Initial pupil diameter (maximum) is one of our outcomes.
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading session3
Pupillary Size Measurement and Reactivity 2
Pupillary Size Measurement and reactivity will be measured in one or both eyes using the NeurOptics PLR-4000 pupillometer device. The eye cup of the hand-held optical scanner system is placed over the participant's eye at a right angle to their axis of vision while the user uses a touchscreen to center the participant's pupil. Once centered, the user initiates the protocol by push-button, and light pulses of 121 uW intensity and 0.80 s duration are used to stimulate pupil reflex and dilation over approximately 6 seconds. Ending diameter (minimum) is another outcome.
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading session4
Pupillary Size Measurement and Reactivity 3
Pupillary Size Measurement and reactivity will be measured in one or both eyes using the NeurOptics PLR-4000 pupillometer device. The eye cup of the hand-held optical scanner system is placed over the participant's eye at a right angle to their axis of vision while the user uses a touchscreen to center the participant's pupil. Once centered, the user initiates the protocol by push-button, and light pulses of 121 uW intensity and 0.80 s duration are used to stimulate pupil reflex and dilation over approximately 6 seconds. Latency (time of onset of constriction following light stimulus) is one of our outcomes.
Time frame
Baseline, 24 hours following the final heading session, 14 days following the final heading sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
United States Department of Defense
Collaborator
University of Rochester
Collaborator
Boston Children's Hospital
Collaborator
University at Buffalo
Collaborator
Source ClinicalTrials.gov