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Completed

NCT Number: NCT02367300

Validation Of TBI Detection System For Head Injured Patients

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.

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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

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About this study

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.

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 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.

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

  1. 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.

    Time frame: 30 days

    The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

BrainScope Company, Inc.

Industry

Registry information

Official study title

Validation Of Point-Of-Care TBI Detection System For Head Injured Patients

Acronym: B-AHEAD III

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 20, 2015
Registry last updated
Jun 21, 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.

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