Allegheny Health Network
Find a
Doctor
Request An Appointment Login to
MyChart
Patient
Center
News Classes &
Events
Contact
Us
Call 412.Doctors

Active Clinical Trials

Emergency Data Gathering and AlphaStroke Refinement (EDGAR)

NCT:
N/A
Allegheny General Hospital
Allegheny General Hospital

Category:
Brain and Nerve
Sponsor: 
Forest Devices, Inc.
Contact: 

For more information, please contact Kelly Szabo at 412-359-8763 or Kelly.Szabo@ahn.org.

Emergency Data Gathering and AlphaStroke Refinement (EDGAR)

Purpose: 

Stage I: The primary objective of Stage I is to capture signals of adequate quality in an ED environment. The secondary objectives of Stage I are:
1) To obtain usability feedback from clinical trial staff members
2) To characterize the disease state and severity of the population of acute neurologic deficits that present to the ED.
Stage 2: The primary objective of Stage 2 is to determine the efficacy of AlphaStroke and 5 brain functional indices (BFIs) in identifying stroke, differentiating ischemic from hemorrhagic stroke, and identification of LVOs. There are three secondary objectives:
1) To capture signal of adequate quality in ED environment
2) To obtain usability feedback from clinical trial staff members
3) To collect safety information
4) To determine clinical efficacy

Inclusion Criteria:

1. The patient has an acute neurological deficit defined as an NIHSS exam score greater than or equal to (≥) 2
2. The subject will be evaluated with diagnostic imaging (CT, CTA, and/or MRI) during their encounter with the healthcare system
3. The subject presents to the emergency department within 8 hours of last known well meeting any one of the following criteria
a. A positive CPSS exam
b. A positive LAPSS exam
c. Meets the requirements or inclusion criteria for the healthcare systems existing stroke alert program activated by EMS or hospital staff

Exclusion Criteria:

1. Below the age of 35
2. Currently pregnant
3. Traumatic injury as cause of symptoms
4. Known History of persistent neurological deficit present longer than 8 hours
5. Status epilepticus or other seizure activity at time of enrollment
6. Known history of the following chronic neurological disorder
a. Brain damage regardless of mechanism
b. Movement disorders (Parkinson’s disease, Tourette’s, multiple sclerosis, etc.)
c. Profound persistent peripheral neuropathy
d. Spinal cord injuries proximal to T12