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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04279431
The ClinicalTrials.gov registry entry for NCT04279431 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 140-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (371% higher). The listed sponsor is BrainScope Company, which has 10 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 3 distinct geographic areas - top geographies include 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.
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