Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02812225|
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Concussion Mild Traumatic Brain Injury||Device: BrainPulse||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
BrainPulse recordings will be obtained from patients when they come in to the ED after a trauma event. BrainPulse recordings will be also obtained from those subjects who also consent for follow-up.
Jan Medical'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 the brain motion using an array of sensors placed on the head.
Other Name: BrainPulse 1100
- Number of BrainPulse recordings from suspected and confirmed concussed subjects [ Time Frame: Through study completion, expected to be 1 year ]The primary endpoint is to enroll and record BrainPulse signals from 500 subjects with a suspected concussion. To gather sufficiently diverse data, at least 300 participants will have had a confirmed diagnosis of concussion. The data will be used to improve the algorithm for aiding in the diagnosis of concussion.
- Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects [ Time Frame: Through study completion, expected to be 1 year ]The secondary endpoint is to compare the BrainPulse readings from patients with confirmed concussion with patients with a suspected concussion in order to study the differences and similarities between the signals. The specific signal patterns observed from confirmed concussed subjects' BrainPulse recordings will be evaluated against the BrainPulse recordings from suspected concussed subjects who are later confirmed to not have a concussion and the percentage of such subjects will be evaluated as part of the secondary outcome. This can be seen as a specificity evaluation.
- Average number of days the signal pattern seen within BrainPulse recordings from confirmed concussed subjects from the initial recording persist over the course of the 21 day follow up period. [ Time Frame: Through study completion, expected to be 1 year ]The tertiary endpoint is to assess the differences in BrainPulse recordings between the initial visit and each subsequent follow-up visit to better understand the recovery process post concussion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812225
|Contact: Prabhu Raghavan, MS, MBA||(650) 567 firstname.lastname@example.org|
|Contact: Hiba Lejmi, MD||(650) 316 email@example.com|
|United States, Massachusetts|
|Beth Israel Deconess Medical Center Emergency Medicine||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Elinita Rosseto 617-754-2334 firstname.lastname@example.org|
|Contact: Ted Raddell (617) 754-2334|
|Principal Investigator: Stephen Epstein, MD, MPP|
|United States, Ohio|
|University of Cincinnati, Department of Emergency Medicine||Recruiting|
|Cincinnati, Ohio, United States, 45267-0769|
|Contact: Christopher Barczak, MT, CCRP 513-558-8091 email@example.com|
|Contact: Cristina Spinner, CCRP (513) 558-0698 firstname.lastname@example.org|
|Principal Investigator: Natalie Kreitzer, MD|
|United States, Tennessee|
|Mountain States Health Alliance||Recruiting|
|Johnson City, Tennessee, United States, 37604|
|Contact: Christy Adkins 423-431-5647 adkinsCE2@msha.com|
|Contact: Nonna Stepanov, MD (423) 431-5647 StepanovNV@msha.com|
|Principal Investigator: Tanzid Shams, MD|