Unblinded Data Collection Study of Concussion Using BrainPulse

NCT ID: NCT02992795

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 353 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-08-31

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.

Conditions

Concussion, Intermediate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort Ia

Athletes in this cohort serve as control subjects participating in Division 1 Athletics at the University of Wyoming. They will be enrolled once they meet eligibility. Upon enrollment, all athletes will have an initial BrainPulse recording. Once a subject from this cohort sustains an injury, they crossover to Cohort II. Also, a matched control for every concussed subject will be selected from Cohort Ia.

BrainPulse

Intervention Type: 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.

Cohort Ib

Athletes in this cohort are subjects currently subscribed to the Head Health Network. They will have a BrainPulse recording completed every week through the entire season. Similarly, if subjects in this cohort sustain an injury, they will crossover to Cohort II.

BrainPulse

Intervention Type: 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.

Cohort IIa

Athletes from Cohort I will be assigned to cohort IIa once they sustain an injury other than concussion. They will have been pulled out of the game by the athletic trainer and removed from play until at least the end of the game. Once the subjects have been assigned to Cohort IIa, they will have a BrainPulse recording and a symptom evaluation within 3 days of their injury. After two weeks of recovery, subjects in this cohort will return to Cohort 1 and resume their participation in the study in their respective sub-cohort.

BrainPulse

Intervention Type: 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.

Cohort IIb

Athletes in this cohort are injured subjects who sustain a non-penetrating head injury and are confirmed to have had a concussion according to the protocol reference standard and by their physician. All subjects enrolled in this cohort are required to have a BrainPulse recording within 3 days of their injury. Each BrainPulse recording will be accompanied by a symptoms evaluation and medical data collection documented in the case report forms. Subjects will complete 3 weeks of follow-up visits post injury.

BrainPulse

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jan Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Wyoming

Laramie, Wyoming, United States

Countries

United States

Other Identifiers

JMC-1602

Identifier Type: -

Identifier Source: org_study_id