Investigation of Neurocognitive Measures of Sport-Related Injury

NCT03414242 | Enrolling By Invitation

• 1 other identifier: 17-006025
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Concussion, Brain

Keywords

brain; concussion; neck; strength; sport; prevention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cervical spine musculature

EXPERIMENTAL

Other: Cervical spine musculature

Interventions

Cervical spine musculature OTHER

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

Cervical spine musculature

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• year old competitive or recreational athletes

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• David Soma, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 29, 2018
• Study Start: March 12, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)