Unblinded Data Collection Study of Concussion Using BrainPulse

Status Completed

Clinical Trial Summary

This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of injury. All subjects will complete a minimum of one recording based on their assigned cohort. Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury. The symptomatic evaluation, physical examination, neurological baseline testing, and BrainPulse recordings will be entered in a database to determine clinical outcome and assess device utilization.

Clinical Trial Description

Cohort I is defined as all enrolled athletes at the University of Wyoming and is divided into two sub-cohorts: Cohort Ia include all athletes participating in Division 1 Athletics; Cohort Ib are athletes subscribed to the Head Health Network. Cohort II is defined as all injured athletes participating in the teams and includes two sub-cohorts: Cohort IIa is defined as non- concussed injured athletes; Cohort IIb concussed athletes per reference standard. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02992795
Study type	Observational
Source	Jan Medical, Inc.
Contact
Status	Completed
Phase
Start date	November 2016
Completion date	August 2017

View Details

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