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

BrainScope Company

Status: Completed

Conditions: Brain Injuries

Treatments: Device: BrainScope Ahead 200

Study type: Observational

Funder types: Industry

Identifiers

NCT02367274

11-Ahead

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 421 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.