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NCT04279431 · ClinicalTrials.gov registry record
Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
A clinical trial of TBI (Traumatic Brain Injury) and Concussion, Brain, sponsored by BrainScope Company.
- Active
- Registry status
- 660
- Enrollment target
- 7
- Study locations
NCT04279431: Active study of TBI (Traumatic Brain Injury) and Concussion, Brain, sponsored by BrainScope Company.
NCT04279431 is a study of TBI (Traumatic Brain Injury) and Concussion, Brain that is active but no longer recruiting, run by BrainScope Company. The registered enrollment target is 660 participants, above the 140-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (371% higher). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04279431, a study of TBI (Traumatic Brain Injury) and Concussion, Brain, is active but no longer recruiting, sponsored by BrainScope Company.
- ACTIVE NOT RECRUITING
- Registry status
- 660 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.
Conditions Studied
Interventions
- OTHER Neurocognitive Tests
- DEVICE EEG Recording
- OTHER Clinician Evaluation
- OTHER 22-item CSI
Study Locations (7)
Michigan
- Wayne State University - Detroit Receiving Hospital - Detroit
- Henry Ford Health System - Detroit
- Wayne State University - Sinai Grace Hospital - Detroit
- Beaumont Hospital - Royal Oak
- Beaumont Hospital - Troy
Missouri
- Washington University - Barnes Jewish Hospital - St Louis
Texas
- El Paso Medical Center - El Paso
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2020-05-25 |
| Est. Completion | 2024-09-30 |
What the registry record for NCT04279431 still lists
NCT04279431 is an observational study that tracks outcomes without assigning an intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, above the 140-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (371% higher).
The record links to 4 conditions, with TBI (Traumatic Brain Injury) appearing as the primary indexed condition, and to 4 interventions - of which Neurocognitive Tests is the first listed.
NCT04279431 lists 7 locations in 3 states (Michigan, Missouri, Texas).
Frequently Asked Questions
What is clinical trial NCT04279431 about?
NCT04279431 is a clinical study titled "Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One". The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to ...
What is the current status of trial NCT04279431?
This trial is currently active not recruiting. The enrollment target is 660 participants. The study started on 2020-05-25. Estimated completion is 2024-09-30.
What conditions does trial NCT04279431 study?
This clinical trial studies the following conditions: TBI (Traumatic Brain Injury), Concussion, Brain, mTBI - Mild Traumatic Brain Injury, Closed Head Injury.
What interventions are being tested in trial NCT04279431?
The interventions under investigation include: Neurocognitive Tests (OTHER), EEG Recording (DEVICE), Clinician Evaluation (OTHER), 22-item CSI (OTHER).
Who is sponsoring clinical trial NCT04279431?
This trial is sponsored by BrainScope Company, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04279431 being conducted?
This trial has 7 study locations across Michigan, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04279431's enrollment target sits among peer trials
660 1st of 20 higher than 20 of 20 other TBI (Traumatic Brain Injury) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other TBI (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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