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NCT02992795 · ClinicalTrials.gov registry record
Unblinded Data Collection Study of Concussion Using BrainPulse
A clinical trial of Concussion, Intermediate, sponsored by Jan Medical.
- Completed
- Registry status
- 353
- Enrollment target
- 1
- Study location
NCT02992795: Completed study of Concussion, Intermediate, sponsored by Jan Medical.
NCT02992795 is a study of Concussion, Intermediate that has completed, run by Jan Medical. The registered enrollment target is 353 participants, above the 198-participant average among 5 other Concussion, Intermediate trials with a reported enrollment target (78% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02992795, a study of Concussion, Intermediate, has completed, sponsored by Jan Medical.
- COMPLETED
- Registry status
- 353 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of injury. All subjects will complete a minimum of one recording based on their assigned cohort. Concussed athletes will complete an additional 3 weeks of follow-up recordings post injury. The symptomatic evaluation, physical examination, neurological baseline testing, and BrainPulse recordings will be entered in a database to determine clinical outcome and assess device utilization.
Primary Outcome
Collect BrainPulse data from at least 15 concussed athletes and matched controls to develop and improve algorithms that can aid in the diagnosis of concussion. The specific signal patterns observed from confirmed concussed subjects' BrainPulse recordings will be evaluated against the BrainPulse recordings from the matched control subjects.
Conditions Studied
Interventions
- DEVICE BrainPulse
Study Locations (1)
Wyoming
- University of Wyoming - Laramie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2016-11 |
| Est. Completion | 2017-08 |
What the finished NCT02992795 record still lists
NCT02992795 is an observational study that tracks outcomes without assigning an intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, above the 198-participant average among 5 other Concussion, Intermediate trials with a reported enrollment target (78% higher).
The record links to 1 condition, with Concussion, Intermediate appearing as the primary indexed condition, and to 1 intervention - of which BrainPulse is the first listed.
NCT02992795 reports a single indexed study location in Wyoming.
Frequently Asked Questions
What is clinical trial NCT02992795 about?
NCT02992795 is a clinical study titled "Unblinded Data Collection Study of Concussion Using BrainPulse". This is a prospective, non-blinded, matched control study of young athletes (ages 10-28 years old) in collegiate sports. The cohorts are defined in accordance to the athlete's exposure of injury. All subjects will complete a minimum of one recording based on their assigned cohort. Concussed athletes...
What is the current status of trial NCT02992795?
This trial is currently completed. The enrollment target is 353 participants. The study started on 2016-11. Estimated completion is 2017-08.
What conditions does trial NCT02992795 study?
This clinical trial studies the following conditions: Concussion, Intermediate.
What interventions are being tested in trial NCT02992795?
The interventions under investigation include: BrainPulse (DEVICE).
Who is sponsoring clinical trial NCT02992795?
This trial is sponsored by Jan Medical, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02992795 being conducted?
This trial has 1 study location across Wyoming. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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