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Investigation of Neurocognitive Measures of Sport-Related Injury

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ClinicalTrials.gov Identifier: NCT03414242
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Hewett, Mayo Clinic

Brief Summary:
The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.

Condition or disease Intervention/treatment Phase
Concussion, Brain Other: Cervical spine musculature Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Investigation of Neurocognitive Measures of Sport-Related Injury
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cervical spine musculature Other: Cervical spine musculature
Previously established cervical spine musculature training methodology will be utilized to develop a concussion prevention training program.




Primary Outcome Measures :
  1. Change in blood metabolite profile [ Time Frame: Through study completion, an athletic season average of 4 months ]
    Blood metabolite profile change from baseline blood draws will be analyzed to determine what blood biomarkers (e.g. amino acids, glycerophospholipids (mg/dL) ) are most sensitive to the presence of a concussion.



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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12-30 year old competitive or recreational athletes

Exclusion Criteria:

  • Pre-existing condition preventing the ability to perform neck range of motion or a neck strength assessment
  • Recent exposure to head lice
  • Known or suspected pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414242


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Timothy Hewett Mayo Clinic

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Responsible Party: Timothy Hewett, Consultant, Orthopedic Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03414242     History of Changes
Other Study ID Numbers: 17-006025
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating