Clinical trial NCT02992795: Unblinded Data Collection Study of Concussion Using BrainPulse
Official title: A Study to Assess the Effectiveness of the BrainPulse as an Aid to the Diagnosis of Concussion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion, Intermediate
Lead sponsor: Jan Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-14
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes participating in Division 1 Athletics at the University of Wyoming

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls
timeFrame: Through study completion, expected to be 8 months
Secondary outcomes:
measure: Correlate helmet sensor's force of impact measurements with BrainPulse data
timeFrame: Through study completion, expected to be 8 months
measure: Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes
timeFrame: Through study completion, expected 8 months
Other outcomes:
Locations:
city: Laramie
country: United States
facility: University of Wyoming
state: Wyoming
Study officials:
References: