Validation Of TBI Detection System For Head Injured Patients

Completed

• Conditions: Brain Injuries

• Registration Number: NCT02367300
• Lead Sponsor: BrainScope Company, Inc.

Brief Summary

A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

Detailed Description

The objective of this study is to validate the clinical utility of the BrainScope technology for the acute identification of structural brain injuries in a TBI population presenting to the ED with mild symptoms, following closed head injury.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-20
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 981

Inclusion Criteria

• Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 72 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).

Exclusion Criteria

• Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.

• In addition,

  • subjects with dementia,
  • Parkinson's Disease,
  • multiple sclerosis,
  • seizure disorder,
  • brain tumors,
  • history of brain surgery,
  • evidence of acute psychosis,
  • substance dependence,
  • history of TIA or stroke within the last year,
  • currently receiving dialysis or in end-stage renal disease,
  • active fever defined as greater than 100 degrees F or 37.7 degrees C,
  • current condition is "critical" in the opinion of the investigator,
  • subject is suffering from an open head injury,
  • subject requires advanced airway management (i.e. mechanical ventilation),
  • currently receiving procedural sedation medications.

• Subjects below the age of 18 years, and prisoners will not be eligible for study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury.	30 days	The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.

Secondary Outcome Measures

Name	Time	Method
To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).	30 days
To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score.	30 days

Trial Locations

Locations (11)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Wayne State University - Sinai Grace Hospital; 🇺🇸 Detroit, Michigan, United States

UT-Houston Health Science Center; 🇺🇸 Houston, Texas, United States

R Cowley Shock Trauma Hospital; 🇺🇸 Baltimore, Maryland, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Emory University- Grady Hospital; 🇺🇸 Atlanta, Georgia, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Wayne State University - Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

Washington University - Barnes Jewish Hospital; 🇺🇸 St. Louis, Missouri, United States