Trials / Completed
CompletedNCT02812225
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 406 (actual)
- Sponsor
- Jan Medical, Inc. · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. In order to gather sufficient variability, subjects with both confirmed concussion and suspected concussion will be included in the study as long as they meet eligibility criteria. BrainPulse recordings from subjects with suspected concussion will be compared to the recordings of subjects diagnosed with concussion. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BrainPulse | 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. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2019-01-01
- Completion
- 2019-01-01
- First posted
- 2016-06-24
- Last updated
- 2022-06-09
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02812225. Inclusion in this directory is not an endorsement.