Skip to main content
OpenTrials
Completed

NCT Number: NCT02992795

Unblinded Data Collection Study of Concussion Using BrainPulse

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Concussion, Intermediate Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wyoming

Laramie, Wyoming, 82070, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female young athletes between ages 18-28 yrs
  • Enrolled at the University of Wyoming and currently participating in Division 1 Athletics
  • Completed the following baseline testing: SWAY balance, King-Devick, C3-Logix
  • Willing and able to participate in all study evaluations and allow access to medical testing and records
  • Signed informed consent, or have a legally authorized representative willing to provide informed consent on behalf of the subject if the subject is a minor

Exclusion criteria

  • Prior concussion diagnosed by a physician in the last 2 weeks assessed via interview with athlete (not including a recent concussion within the last 3 days)
  • Any serious medical, social or psychological condition that in the opinion of the investigator would impair ability to provide informed consent or otherwise disqualify a patient from participation

Treatment and study plan

BrainPulse

Device

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.

Primary outcomes

  1. Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls

    Time frame: Through study completion, expected to be 8 months

    Collect BrainPulse data from at least 15 concussed athletes and matched controls to develop and improve algorithms that can aid in the diagnosis of concussion.

    The specific signal patterns observed from confirmed concussed subjects' BrainPulse recordings will be evaluated against the BrainPulse recordings from the matched control subjects.

Secondary outcomes

  1. Correlate helmet sensor's force of impact measurements with BrainPulse data

    Time frame: Through study completion, expected to be 8 months

    Compare the magnitude of force measured by helmet sensors from subconcussive hits with consecutive BrainPulse recordings. As such, BrainPulse data on these athletes will be compared with helmet sensor data, baseline cognitive testing, and the initial BrainPulse recording.

  2. Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes

    Time frame: Through study completion, expected 8 months

    Compare BrainPulse signals in subjects sustaining a non-concussive injury to subjects that have a confirmed diagnosis of concussion. Also compare BrainPulse signals from injured subjects in Cohort IIa with non-injured subjects in Cohort Ia.

Sponsors and collaborators

Lead sponsor

Jan Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 14, 2016
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.