Unblinded Data Collection Study of Concussion Using BrainPulse
Completed
Conditions studied: Concussion, Intermediate
In brief
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.
Key facts
- Study ID
- NCT02992795
- Run by
- Jan Medical, Inc.
- People needed
- 353
- Starts
- 2016-11-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2018-09-20
Who can join
Age: 18 and older, up to 28. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Wyoming — Laramie, Wyoming, United States
Full record on ClinicalTrials.gov
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