- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02992795
Unblinded Data Collection Study of Concussion Using BrainPulse
September 18, 2018 updated by: Jan Medical, Inc.
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
353
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wyoming
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Laramie, Wyoming, United States, 82070
- University of Wyoming
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Athletes participating in Division 1 Athletics at the University of Wyoming
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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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.
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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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of BrainPulse recordings of concussed subjects with BrainPulse recordings from their matched Controls
Time Frame: Through study completion, expected to be 8 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlate helmet sensor's force of impact measurements with BrainPulse data
Time Frame: Through study completion, expected to be 8 months
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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.
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Through study completion, expected to be 8 months
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Compare BrainPulse Data between Injured Athletes, Non-Injured athletes, and Concussed Athletes
Time Frame: Through study completion, expected 8 months
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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.
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Through study completion, expected 8 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
December 12, 2016
First Submitted That Met QC Criteria
December 12, 2016
First Posted (Estimate)
December 14, 2016
Study Record Updates
Last Update Posted (Actual)
September 20, 2018
Last Update Submitted That Met QC Criteria
September 18, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JMC-1602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All study outcome measures will be made available within 6 months of study completion
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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