Back to resultsInvestigation of Neurocognitive Measures of Sport-Related Injury
Primary Purpose
Concussion, Brain
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical spine musculature
Sponsored by
About this trial
This is an interventional screening trial for Concussion, Brain focused on measuring brain, concussion, neck, strength, sport, prevention
Eligibility 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
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic in Florida
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cervical spine musculature
Arm Description
Outcomes
Primary Outcome Measures
Change in blood metabolite profile
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03414242
Brief Title
Investigation of Neurocognitive Measures of Sport-Related Injury
Official Title
Investigation of Neurocognitive Measures of Sport-Related Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
Keywords
brain, concussion, neck, strength, sport, prevention
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cervical spine musculature
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cervical spine musculature
Intervention Description
Previously established cervical spine musculature training methodology will be utilized to develop a concussion prevention training program.
Primary Outcome Measure Information:
Title
Change in blood metabolite profile
Description
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.
Time Frame
Through study completion, an athletic season average of 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stuart, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Investigation of Neurocognitive Measures of Sport-Related Injury
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