Status:
ACTIVE_NOT_RECRUITING
Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
Lead Sponsor:
BrainScope Company, Inc.
Conditions:
TBI (Traumatic Brain Injury)
Concussion, Brain
Eligibility:
All Genders
18-85 years
Brief Summary
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One struc...
Detailed Description
BrainScope One incorporates brain electrical activity (EEG, a proven electrophysiological core technology) and other multimodal assessment capabilities in a portable, point-of-care, non-invasive devic...
Eligibility Criteria
Inclusion
- Patient can be of any gender;
- Patient must be admitted to the ED with a traumatic closed head injury within 72 hours of injury;
- Patient's Age must be ≥18 and \<86 years old at time of enrollment;
- Patient must be Glasgow Coma Scale (GCS) 14-15 at time of BrainScope evaluation (even if GCS was lower prior to arrival e.g. at time of injury).
Exclusion
- Patients with forehead, scalp, earlobe or skull abnormalities or other conditions that would prevent correct application of the electrode headset;
- Patients with Dementia, Parkinson's Disease, Multiple Sclerosis, brain tumors, history of brain surgery, evidence of acute psychosis or history of stroke with neurological deficit within the last year;
- Patients on anti-platelets, anti-coagulants, other than aspirin, currently receiving dialysis or in end-stage renal disease or current condition is "critical" in the opinion of the investigator;
- Patients with active fever defined as greater than 100oF or 37.7oC;
- Patients suffering from an open head injury or have suffered multi-trauma which requires hospitalization (for injuries not related to the head injury)
- Patients requiring advanced airway management (i.e. mechanical ventilation);
- Patients currently receiving procedural sedation medications (e.g. benzodiazepine, anesthetic, NMDA receptor antagonist, or opioid agonist) Note: patient can be enrolled when they are no longer obtunded and have the capacity to consent;
- Pregnant women and prisoners;
- Patients who have had a Head CT scan for current traumatic injury event prior to screening.
Key Trial Info
Start Date :
May 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT04279431
Start Date
May 25 2020
End Date
September 30 2024
Last Update
September 3 2024
Active Locations (7)
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1
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, United States, 48235
4
Beaumont Hospital
Royal Oak, Michigan, United States, 48073