Validation Of TBI Detection System For Head Injured Patients

Completed

Conditions studied: Brain Injuries

In brief

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.

Key facts

Study ID

NCT02367300

Run by

BrainScope Company, Inc.

People needed

981

Starts

2015-02-01

Expected to finish

2016-01-01

Last updated by the study team

2016-06-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• Emory University- Grady Hospital — Atlanta, Georgia, United States
• R Cowley Shock Trauma Hospital — Baltimore, Maryland, United States
• Wayne State University - Detroit Receiving Hospital — Detroit, Michigan, United States
• Wayne State University - Sinai Grace Hospital — Detroit, Michigan, United States
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• UT-Houston Health Science Center — Houston, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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