Head InjuriesMONITOR-RHINCT06810193
Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
A study testing Aerobic exercise in people with Head Injuries, run by University of Rochester at 3 sites in United States.
Trial summary
The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Injuries
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jul 2025to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Collegiate athlete or athlete-cadet anticipated to be an active member of a varsity sport team.
Who cannot join
- Any head, neck, or face injury in the 3 months prior to enrollment that precludes participation in contact sports or wearing a mouth guard sensor
- History of neurological or psychiatric disorders or neurological disorders that impact electrical activity in the brain (such as seizure disorders), or diagnosed learning disability, that in the opinion of the investigator, would interfere with participation in the study.
- Participants currently undergoing active treatment for migraine, depression and/or anxiety or ADHD will not be excluded as these are high prevalence conditions in the adolescent and collegiate population (8-30%). However, exploratory stratified analyses will be conducted where possible.
- Participants with eye conditions or diseases that could impact the blood vessels in the eye.
- 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 Site Investigator or Study PI.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University at Buffalo
Amherst, New York, 14221
The Citadel, The Military College of South Carolina
Charleston, South Carolina, 29409
University of Rochester
Rochester, New York, 14620
About this study
The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.
Read the detailed description
Up to 350 total collegiate athletes and athlete-cadets will be enrolled. Approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the Observational arm; approximately half the participants will be female.
- Conditions
- Head Injuries
- Being tested
- Aerobic exercise
- Keywords
- Repetitive Head Impacts
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
After the end-of-season assessments, participants in the Intervention (Exercise or Stretching) arm will be randomized to 2 weeks of daily aerobic exercise for 30 minutes or to 30-minutes of prescribed stretching.
| Study group | Role | What they receive |
|---|---|---|
| Observational (Ad-Lib Exercise) Arm | No intervention | All participants will undergo neurologic outcome testing with optical coherence tomography/angiography (OCT/A) at pre- and post-season and 2 weeks after the end of the season. For two weeks at the end of the sport season, participants will be instructed to refrain from sports involving head contact but to otherwise exercise ad-lib. |
| Intervention (Exercise or Stretching) Arm | Experimental | Athletes and athlete cadets will be administered OCT/A and a novel neurologic test battery at pre- and post-season, and 2 weeks after the end of the season. After the end-of-season assessments, participants will be randomized to 2 weeks of either 30 minutes of daily aerobic exercise or to 30-minutes of prescribed stretching. Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)
A primary OCT variables examined will be macula cerebrospinal fluid (CSF) thickness (an indicator of the gain or loss of neurons or glia in the inner nuclear, ganglion cell and nerve fiber layer).
Measured: Pre-season and post-season, 2 weeks
Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP)
Glial Fibrillary Acidic Protein (GFAP) concentration will determine if there is a 11.9 pg/mL or greater change in GFAP in each participant over the course of the study.
Measured: Baseline 4 to 7 months
Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample
The neurologic test battery consists of blood draws for serum brain proteins: Neurofilament light chain (NfL) concentrations will be observed for changes over the course of the study.
Measured: Baseline 4 to 7 months
Change in p-231Tau serum concentration in a blood sample
The neurologic test battery consists of blood draws for serum brain proteins: p231Tau will be observed for changes over the course of the study.
Measured: Baseline 4 to 7 months
Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG)
The Quantitative Electroencephalogram (qEEG) Concussion Index (CI) includes measures of power (absolute and relative), mean frequency, connectivity (asymmetry, coherence, phase lag, phase synchrony), complexity (fractal dimension and scale-free activity), and information theory (entropy), across and within frequency bands.
Measured: Baseline 4 to 7 months
Change in near-point convergence (NPC)
Near point of convergence (NPC) is a measurement of how close an object can be brought to the eyes while the eyes are focused on it.
Measured: Baseline 4 to 7 months
Change in Choice reaction time (CRT)
Choice reaction time (CRT) refers to the time it takes for a person to react to a stimulus by selecting a specific response from multiple options.
Measured: Baseline 4 to 7 months
Change in blink reflex test
A blink reflex test, also known as a corneal reflex test, is a non-invasive procedure that measures the electrical activity of the facial nerves when stimulated.
Measured: Baseline 4 to 7 months
Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina
OCT will be used to measure the cup-to-disc ratio of the optic disc, and indicator of neurodegeneration.
Measured: Pre-season and post-season, 2 weeks
Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retina
Retinal vascular structure will be acquired using the OCT angiography (OCT/A). The primary OCT/A variable examined will be foveal avascular zone (FAZ) area reflecting the size of the central portion of the macula which contains no blood vessels, and which increases in size with loss of capillaries in the surrounding region).
Measured: Pre-season and post-season, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start23 Jul 2025
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuriesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Bazarian, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810193
- Sponsor's protocol ID
- STUDY00010101
- Other IDs
- US Department of Defense
- Acronym
- MONITOR-RHI
- Status last verified
- Sep 2025
- First submitted
- 25 Jan 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring & Mitigation of Neurologic Injuries to Optimize Resilience After Repetitive Head Impacts
- ClinicalTrials.gov ID
- NCT06810193
- Acronym / sponsor ID
- MONITOR-RHI / STUDY00010101
- Conditions
- Head Injuries
- Keywords
- Repetitive Head Impacts
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 5 Feb 2025 (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 Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.
Detailed description
Up to 350 total collegiate athletes and athlete-cadets will be enrolled. Approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the Observational arm; approximately half the participants will be female.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational (Ad-Lib Exercise) Arm | No intervention | –All participants will undergo neurologic outcome testing with optical coherence tomography/angiography (OCT/A) at pre- and post-season and 2 weeks after the end of the season. For two weeks at the end of the sport season, participants will be instructed to refrain from sports involving head contact but to otherwise exercise ad-lib. |
| Intervention (Exercise or Stretching) Arm | Experimental | Other: Aerobic exerciseAthletes and athlete cadets will be administered OCT/A and a novel neurologic test battery at pre- and post-season, and 2 weeks after the end of the season. After the end-of-season assessments, participants will be randomized to 2 weeks of either 30 minutes of daily aerobic exercise or to 30-minutes of prescribed stretching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Collegiate athlete or athlete-cadet anticipated to be an active member of a varsity sport team.
Key exclusion criteria (5 listed)
- Any head, neck, or face injury in the 3 months prior to enrollment that precludes participation in contact sports or wearing a mouth guard sensor
- History of neurological or psychiatric disorders or neurological disorders that impact electrical activity in the brain (such as seizure disorders), or diagnosed learning disability, that in the opinion of the investigator, would interfere with participation in the study.
- Participants currently undergoing active treatment for migraine, depression and/or anxiety or ADHD will not be excluded as these are high prevalence conditions in the adolescent and collegiate population (8-30%). However, exploratory stratified analyses will be conducted where possible.
- Participants with eye conditions or diseases that could impact the blood vessels in the eye.
- 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 Site Investigator or Study PI.
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 |
|---|---|---|
| Aerobic exerciseAfter the end-of-season assessments, participants in the Intervention (Exercise or Stretching) arm will be randomized to 2 weeks of daily aerobic exercise for 30 minutes or to 30-minutes of prescribed stretching. | Other | Intervention (Exercise or Stretching) Arm |
Primary outcome
Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina)
Time frame: Pre-season and post-season, 2 weeks
A primary OCT variables examined will be macula cerebrospinal fluid (CSF) thickness (an indicator of the gain or loss of neurons or glia in the inner nuclear, ganglion cell and nerve fiber layer).
Change in Blood Serum Concentrations of Glial Fibrillary Acidic Protein (GFAP)
Time frame: Baseline 4 to 7 months
Glial Fibrillary Acidic Protein (GFAP) concentration will determine if there is a 11.9 pg/mL or greater change in GFAP in each participant over the course of the study.
Change in Blood Serum Concentration of Neurofilament light chain (NfL) in a blood sample
Time frame: Baseline 4 to 7 months
The neurologic test battery consists of blood draws for serum brain proteins: Neurofilament light chain (NfL) concentrations will be observed for changes over the course of the study.
Change in p-231Tau serum concentration in a blood sample
Time frame: Baseline 4 to 7 months
The neurologic test battery consists of blood draws for serum brain proteins: p231Tau will be observed for changes over the course of the study.
Change in Concussion Index as measured with Quantitative Electroencephalogram (qEEG)
Time frame: Baseline 4 to 7 months
The Quantitative Electroencephalogram (qEEG) Concussion Index (CI) includes measures of power (absolute and relative), mean frequency, connectivity (asymmetry, coherence, phase lag, phase synchrony), complexity (fractal dimension and scale-free activity), and information theory (entropy), across and within frequency bands.
Change in near-point convergence (NPC)
Time frame: Baseline 4 to 7 months
Near point of convergence (NPC) is a measurement of how close an object can be brought to the eyes while the eyes are focused on it.
Change in Choice reaction time (CRT)
Time frame: Baseline 4 to 7 months
Choice reaction time (CRT) refers to the time it takes for a person to react to a stimulus by selecting a specific response from multiple options.
Change in blink reflex test
Time frame: Baseline 4 to 7 months
A blink reflex test, also known as a corneal reflex test, is a non-invasive procedure that measures the electrical activity of the facial nerves when stimulated.
Optical Coherence Tomography (OCT) to detect signs of neurodegenertaion in the Retina
Time frame: Pre-season and post-season, 2 weeks
OCT will be used to measure the cup-to-disc ratio of the optic disc, and indicator of neurodegeneration.
Optical Coherence Tomography/Angiography (OCT/A) to assess the vascular structure in the retina
Time frame: Pre-season and post-season, 2 weeks
Retinal vascular structure will be acquired using the OCT angiography (OCT/A). The primary OCT/A variable examined will be foveal avascular zone (FAZ) area reflecting the size of the central portion of the macula which contains no blood vessels, and which increases in size with loss of capillaries in the surrounding region).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Head Injuries, run by University of Rochester at 3 sites 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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Optical Coherence Tomography (OCT) of Cerebrospinal Fluid Thickness in the Macula (Part of the Retina) (time frame: Pre-season and post-season, 2 weeks). The study lists 10 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 11 Sep 2025.