Unblinded Data Collection Study of Concussion Using BrainPulse
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 28 |
| Updated: | 9/22/2018 |
| Start Date: | November 2016 |
| End Date: | August 2017 |
A Study to Assess the Effectiveness of the BrainPulse as an Aid to the Diagnosis of Concussion
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.
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.
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.
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.
Inclusion Criteria:
1. Male or female young athletes between ages 18-28 yrs
2. Enrolled at the University of Wyoming and currently participating in Division 1
Athletics
3. Completed the following baseline testing: SWAY balance, King-Devick, C3-Logix
4. Willing and able to participate in all study evaluations and allow access to medical
testing and records
5. 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:
1. 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)
2. 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
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