NCT02367274

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 421 (actual)
• Sponsor: BrainScope Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Brain Injuries

Interventions

Type	Name	Description
DEVICE	BrainScope Ahead 200	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-01
• Completion: 2016-04-01
• First posted: 2015-02-20
• Last updated: 2016-04-19

Locations

11 sites across 1 country: United States