NCT02992795

Unblinded Data Collection Study of Concussion Using BrainPulse

A Study to Assess the Effectiveness of the BrainPulse as an Aid to the Diagnosis of Concussion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 353 (actual)
• Sponsor: Jan Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Concussion, Intermediate

Interventions

Type	Name	Description
DEVICE	BrainPulse	JanMedical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to tge brain motion using an array of sensors placed on the head.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2016-12-14
• Last updated: 2018-09-20

Locations

1 site across 1 country: United States