Validation Of TBI Detection System For Head Injured Patients (B-AHEAD III)

BrainScope Company

Status: Completed

Conditions: Brain Injuries

Treatments: Device: BrainScope Ahead 200

Study type: Observational

Funder types: Industry

Identifiers

NCT02367300

22-Ahead

Details and patient eligibility

About

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.

Full 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.

Enrollment: 981 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 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.