Cerebral InjuryNCT03394248
The Effects of Subconcussive Events on Cognition
An observational study of Cerebral Injury, run by New York Institute of Technology at 1 site in United States.
Trial summary
The purpose of this study is to determine early detection of concussion for those at risk of developing symptoms and to be able to detect subconcussive cerebral impairment, and thus gaining a better understanding of the injury patterns for concussions in Men's and Women's Collegiate sports. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Injury
- What is being tested?
- Vector Mouthguard
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 13 Mar 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects for this study will be members of the NYIT Athletic Teams.
Who may be able to join
- Subject is at least 18 years age and younger than 50 years of age
- Subject experiences at least 8Gs of force on at least one occasion, as measured by accelerometer
Who cannot join
- The subject suffered from any of the following at the time of event leading to a concussion:
- Loss of consciousness >2 minutes in the field as reported by witness
- Seizures
- Intractable vomiting
- Paralysis
- The subject has been diagnosed with an underlying neurodegenerative condition that may confound test results (e.g. Parkinson's Disease, Alzheimer's Disease)
Show all 9Show fewer
- The subject has a current or previous spinal cord injury
- The subject is unable to complete assessment tools
- The subject is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11568
About this study
The purpose of this study is to determine early detection of concussion for those at risk of developing symptoms and to be able to detect subconcussive cerebral impairment, and thus gaining a better understanding of the injury patterns for concussions in Men's and Women's Collegiate sports.
Read the detailed description
Description of the Research Subjects will be members of NYIT's Collegiate Athletic Teams. Potential subjects will be informed about the proposed study and asked if the athlete is interested in participating. If the athlete agrees, the key investigator will review the study procedures, what is expected of the subject, and complete the informed consent process. Participation will be completely voluntary and will have no impact on the quality of care the subject will receive. Inclusion and exclusion criteria will then be evaluated by the key investigator to determine if the subject is qualified to participate in this study. Following consent and review of inclusion and exclusion criteria, the subject will be assigned a subject identification number in which is intended to maintain confidentiality of the subject's personal health information. The number will be used for the duration of the study and in all analyses. Once enrolled, the subjects will complete a baseline questionnaire* that will include demographic information and personal history, as well as consent for de-identified information to be shared with a third party, Quadrant Biosciences, for research purposes. The subjects will be evaluated by a series of measurements, ClearEdge, Quadrant Bioscience Salivary Testing, King Devick, and Im PACT, in the preseason, midseason, and postseason, or if they are suspected of a concussion by the athletic trainer or team physician. Visit 1: Baseline Data Collection
- Assessment Tools
- Demographic/Baseline questionnaire*
- ImPACT
- King-Devick
- ClearEdge New York Institute of Technology Institutional Review Board Approved From 07/18/20 to 07/17/21
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated Time: 1.5 hours Visit 2: Mid-Season Collection
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hour Visit 3: Post-season Data Collection
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hr Visit 4: If athlete is suspected to have sustained a concussion by the athletic trainer or team physician, the athlete will come for an additional visit
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hr
- Conditions
- Cerebral Injury
- Being tested
- Vector Mouthguard
- Keywords
- Subconcussive head injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vector MouthguardDevice
The mouthguard will be used by athletes to measure the magnitude and number of impacts throughout one season.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognition secondary to impact
A mouthguard with built in sensors to collect data above the predetermined acceleration thresholds. The predetermined threshold for acceleration will be set to 5G in order to collect more data about subconcussive impacts, in addition to concussive impacts
Measured: 5 months
Secondary outcomes (3)
ImPACT Testing
Tool to help detect and assess the severity of concussion in athletes by establishing a baseline of memory and cognitive function
Measured: 5 months
King-Devick Test
Objectively measures visual tracking and saccadic eye movements
Measured: 5 months
C3 Logix
Concussion Assessment application with the ability to track a patient's dynamic vision reflexes and ability to focus on moving objects
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start26 Jan 2018
- Primary completion3 Jul 2018
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Heller, New York Institute of Technology
- Investigators
- Matthew Heller, D.O, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394248
- Sponsor's protocol ID
- BHS-1304
- Status last verified
- Apr 2022
- First submitted
- 20 Dec 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May share with osteopathic medical research students
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Subconcussive Events on Cognition
- ClinicalTrials.gov ID
- NCT03394248
- Acronym / sponsor ID
- BHS-1304
- Conditions
- Cerebral Injury
- Keywords
- Subconcussive head injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 9 Jan 2018 (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 determine early detection of concussion for those at risk of developing symptoms and to be able to detect subconcussive cerebral impairment, and thus gaining a better understanding of the injury patterns for concussions in Men's and Women's Collegiate sports.
Detailed description
Description of the Research Subjects will be members of NYIT's Collegiate Athletic Teams. Potential subjects will be informed about the proposed study and asked if the athlete is interested in participating. If the athlete agrees, the key investigator will review the study procedures, what is expected of the subject, and complete the informed consent process. Participation will be completely voluntary and will have no impact on the quality of care the subject will receive. Inclusion and exclusion criteria will then be evaluated by the key investigator to determine if the subject is qualified to participate in this study. Following consent and review of inclusion and exclusion criteria, the subject will be assigned a subject identification number in which is intended to maintain confidentiality of the subject's personal health information. The number will be used for the duration of the study and in all analyses. Once enrolled, the subjects will complete a baseline questionnaire* that will include demographic information and personal history, as well as consent for de-identified information to be shared with a third party, Quadrant Biosciences, for research purposes. The subjects will be evaluated by a series of measurements, ClearEdge, Quadrant Bioscience Salivary Testing, King Devick, and Im PACT, in the preseason, midseason, and postseason, or if they are suspected of a concussion by the athletic trainer or team physician. Visit 1: Baseline Data Collection
- Assessment Tools
- Demographic/Baseline questionnaire*
- ImPACT
- King-Devick
- ClearEdge New York Institute of Technology Institutional Review Board Approved From 07/18/20 to 07/17/21
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated Time: 1.5 hours Visit 2: Mid-Season Collection
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hour Visit 3: Post-season Data Collection
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hr Visit 4: If athlete is suspected to have sustained a concussion by the athletic trainer or team physician, the athlete will come for an additional visit
- Assessment Tools
- ImPACT
- King-Devick
- ClearEdge
- Quadrant Bioscience Salivary Testing
- Quadrant Bioscience Salivary Testing Questionnaire
- Estimated time: 1 hr
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects for this study will be members of the NYIT Athletic Teams.
Key inclusion criteria (2 listed)
- Subject is at least 18 years age and younger than 50 years of age
- Subject experiences at least 8Gs of force on at least one occasion, as measured by accelerometer
Key exclusion criteria (9 listed)
- The subject suffered from any of the following at the time of event leading to a concussion:
- The subject has been diagnosed with an underlying neurodegenerative condition that may confound test results (e.g. Parkinson's Disease, Alzheimer's Disease)
- The subject has a current or previous spinal cord injury
- The subject is unable to complete assessment tools
- The subject is pregnant
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 |
|---|---|---|
| Vector MouthguardThe mouthguard will be used by athletes to measure the magnitude and number of impacts throughout one season. | Device | – |
Primary outcome
Changes in cognition secondary to impact
Time frame: 5 months
A mouthguard with built in sensors to collect data above the predetermined acceleration thresholds. The predetermined threshold for acceleration will be set to 5G in order to collect more data about subconcussive impacts, in addition to concussive impacts
3 secondary outcomes
ImPACT Testing
Time frame: 5 months
King-Devick Test
Time frame: 5 months
C3 Logix
Time frame: 5 months
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 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. May share with osteopathic medical research students
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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.
Matthew Heller, D.O principal investigator
New York Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Injury, run by New York Institute of Technology 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 2 inclusion and 9 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 14 Apr 2022. 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. 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?
Changes in cognition secondary to impact (time frame: 5 months). 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 14 Apr 2022.