Investigation of Neurocognitive Measures of Sport-Related Injury

December 15, 2023 updated by: David B. Soma, Mayo Clinic
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an athletic season average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: David Soma, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-006025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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