Point-Of-Care TBI Detection System For Head Injured Patients In The Emergency Department

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

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hartford Hospital, Hartford, Connecticut, United States

About this study

The objective of this study is to test the clinical utility of the BrainScope technology for the acute identification of traumatic structural brain injury in the TBI population, following closed head injury. The data generated will serve to validate and/or refine the current algorithms to detect acute, traumatic, structural brain injury.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 24 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,
psychiatric disorder being managed by a psychiatric healthcare professional/provider,
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.

Treatment and study plan

BrainScope Ahead 200

Device

A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.

Primary outcomes

Extend and replicate a database of brain electrical activity and clinical information collected from patients who present to the ED following closed head injury

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

BrainScope Company, Inc.

Industry

Registry information

Official study title

Use Of A Point-Of-Care TBI Detection System For Identification Of Head Injured Patients Who Present To The Emergency Department

Acronym: READ-TBI

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2016
First posted: Feb 20, 2015
Registry last updated: Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed