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NCT03414242 Clinical Trial

Investigation of Neurocognitive Measures of Sport-Related Injury

Concussion, Brain Clinical Trial

Official title:
Investigation of Neurocognitive Measures of Sport-Related Injury

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03414242
Other study ID # 17-006025
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 12, 2019
Est. completion date December 2028

Study information
Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 4000
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group 12 Years to 30 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cervical spine musculature
Previously established cervical spine musculature training methodology will be utilized to develop a concussion prevention training program.

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an athletic season average of 4 months
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