Unblinded Data Collection Study of Concussion Using BrainPulse

Concussion, Intermediate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992795
• Other study ID #: JMC-1602
• Status: Completed
• Start date: November 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2018
• Source: Jan Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Intermediate

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Wyoming	Laramie	Wyoming

Sponsors (1)

Lead Sponsor	Collaborator
Jan Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls	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.	Through study completion, expected to be 8 months
Secondary	Correlate helmet sensor's force of impact measurements with BrainPulse data	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.	Through study completion, expected to be 8 months
Secondary	Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes	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.	Through study completion, expected 8 months