Trials / Completed
CompletedNCT02367300
Validation Of TBI Detection System For Head Injured Patients
Validation Of Point-Of-Care TBI Detection System For Head Injured Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 981 (actual)
- Sponsor
- BrainScope Company, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
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
- 2015-02-01
- Primary completion
- 2015-12-01
- Completion
- 2016-01-01
- First posted
- 2015-02-20
- Last updated
- 2016-06-21
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02367300. Inclusion in this directory is not an endorsement.