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
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

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

External Links

•   Mayo Clinic Clinical Trials