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NCT02812225 · ClinicalTrials.gov registry record
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
A clinical trial of Mild Traumatic Brain Injury and Brain Concussion, sponsored by Jan Medical.
- Completed
- Registry status
- 406
- Enrollment target
- 3
- Study locations
NCT02812225: Completed study of Mild Traumatic Brain Injury and Brain Concussion, sponsored by Jan Medical.
NCT02812225 is a study of Mild Traumatic Brain Injury and Brain Concussion that has completed, run by Jan Medical. The registered enrollment target is 406 participants, above the 211-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (92% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02812225, a study of Mild Traumatic Brain Injury and Brain Concussion, has completed, sponsored by Jan Medical.
- COMPLETED
- Registry status
- 406 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE BrainPulse
Study Locations (3)
Massachusetts
- Beth Israel Deconess Medical Center Emergency Medicine - Boston
Ohio
- University of Cincinnati, Department of Emergency Medicine - Cincinnati
Tennessee
- Mountain States Health Alliance - Johnson City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2016-06 |
| Est. Completion | 2019-01 |
What the finished NCT02812225 record still lists
NCT02812225 is an observational study that tracks outcomes without assigning an intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, above the 211-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (92% higher).
The record links to 2 conditions, with Mild Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which BrainPulse is the first listed.
NCT02812225 reports a single indexed study location in Massachusetts, Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT02812225 about?
NCT02812225 is a clinical study titled "Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)". 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.
What is the current status of trial NCT02812225?
This trial is currently completed. The enrollment target is 406 participants. The study started on 2016-06. Estimated completion is 2019-01.
What conditions does trial NCT02812225 study?
This clinical trial studies the following conditions: Mild Traumatic Brain Injury, Brain Concussion.
What interventions are being tested in trial NCT02812225?
The interventions under investigation include: BrainPulse (DEVICE).
Who is sponsoring clinical trial NCT02812225?
This trial is sponsored by Jan Medical, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02812225 being conducted?
This trial has 3 study locations across Massachusetts, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mild Traumatic Brain Injury
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Where NCT02812225's enrollment target sits among peer trials
406 6th of 43 higher than 38 of 43 other Mild Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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