Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-04 @ 8:45 PM
Study NCT ID:
NCT02849002
Status:
TERMINATED
Last Update Posted:
2023-07-07
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
Sponsor:
Jan Medical, Inc.
Organization:
Study Overview
Official Title:
Non-Blinded Data Collection Study Of Concussion Using The BrainPulse
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped at site due to insufficient funding to continue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by Jan Medical, Inc. Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to study the subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a database to assess clinical outcome and device utilization.BrainPulse(TM)
Detailed Description:
Jan Medical is conducting a data collection study with the goal of developing further insight into understanding the signal features within a BrainPulse recording that are only present when the subject has a confirmed concussion. The initial pilot blinded study with Stanford University showed that there is increased energy in the 8-15 Hz range for BrainPulse recordings from adolescent male football players with a confirmed concussion. The current un-blinded study is designed to record the BrainPulse signal from a more diverse subject population to represent patients who have been diagnosed with a concussion in clinic setting. Subjects will include males and females ages 13 and older.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: