NCT02812225|CompletedDMC
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Sponsor study identifier
observational
406
1 country
3
Study Start
June 2016
Actual (reported)Primary Completion
January 2019
Actual (reported)Study Completion
January 2019
Actual (reported)The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm. Subjects may also consent for a 5 additional follow-ups over a 21-day period to compare the progression of change in their BrainPulse recordings.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2016
Actual (reported)June 20, 2016
Actual (reported)June 24, 2016
Actual (reported)January 2019
Actual (reported)January 2019
Actual (reported)Number of BrainPulse recordings from suspected and confirmed concussed subjects
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.
Through study completion, expected to be 1 year
Specificity: Percentage of BrainPulse recordings from suspected concussed subjects that do not have the signal pattern seen within BrainPulse recordings from confirmed concussed subjects
Through study completion, expected to be 1 year
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.
Through study completion, expected to be 1 year
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients presenting to a hospital emergency department with a mechanism of injury and clinical presentation that is consistent with concussion
Beth Israel Deconess Medical Center Emergency Medicine
Boston, Massachusetts, 02215, United States
University of Cincinnati, Department of Emergency Medicine
Cincinnati, Ohio, 45267-0769, United States
Mountain States Health Alliance
Johnson City, Tennessee, 37604, United States
Auerbach PS, Baine JG, Schott ML, Greenhaw A, Acharya MG, Smith WS. Detection of concussion using cranial accelerometry. Clin J Sport Med. 2015 Mar;25(2):126-32. doi: 10.1097/JSM.0000000000000117.
Smith WS, Browne JL, Ko NU. Cranial Accelerometry Can Detect Cerebral Vasospasm Caused by Subarachnoid Hemorrhage. Neurocrit Care. 2015 Dec;23(3):364-9. doi: 10.1007/s12028-015-0118-9.
Coscia A, Stolz U, Barczak C, Wright N, Mittermeyer S, Shams T, Epstein S, Kreitzer N. Use of the Sports Concussion Assessment Tool 3 in Emergency Department Patients With Psychiatric Disease. J Head Trauma Rehabil. 2021 Sep-Oct 01;36(5):E302-E311. doi: 10.1097/HTR.0000000000000648.
406 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2016
First Posted
June 24, 2016
Study Start
June 2016
Actual (reported)EyeBOX Concussion Study and Registry
Contact the study team to confirm eligibility.
Primary Completion
January 2019
Actual (reported)Study Completion
January 2019
Actual (reported)Last Updated
June 9, 2022
Record last verified: 2022-06
All primary and secondary outcome measures will be made available within 6 months of study completion.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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