Traumatic Brain Injury Feasibility Study (EPIC-011) (TBI)

Epic Research & Diagnostics

Status: Unknown

Conditions: Traumatic Brain Injury; Controls

Treatments: Device: ClearView Scanning

Study type: Observational

Funder types: Industry

Identifiers

NCT02471625

EPIC-011

Details and patient eligibility

About

The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.

Full description

Traumatic brain injury (TBI) is a significant cause of death and disability in the U.S. The severity of a TBI may range from "mild" (i.e. a brief change in mental status or consciousness) to "severe" (i.e. an extended period of unconsciousness or memory loss after the injury). However, most TBI's that occur each year are mild and are commonly called concussions. Unfortunately, TBI terminology does not adequately describe the injury or impairment, its treatment, or the resulting outcomes. Due to the complexity of the human brain, each person's physiology can result in different patterns of impairment and secondary conditions, requiring different treatment or rehabilitation. The intent of EPIC ClearView™ TBI Feasibility (EPIC-011) is to collect data to further develop the ClearView™ Response Scale to measure electrophysiology associated with TBI

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Suspected TBI population:

1. Acute head trauma within 24-72 hours of presentation
2. 18-65 age inclusive
3. GCS of 3-15 on initial evaluation in ED

Control population:

1. 18-65 age inclusive
2. GCS score of 15

Exclusion criteria

1. Current neurological disease
2. Current severe psychological disorder
3. History of substance or alcohol abuse
4. Under drug or alcohol influence, if so, must wait at least 24 hrs. prior to consent
5. Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
6. Current treatment to the head/brain (radiation, whole brain therapy, gamma knife)
7. Head injury in the last two years
8. Unwilling to sign informed consent
9. Pregnant or potentially pregnant
10. Pacemaker, automatic implanted cardiac defibrillator or other implanted electrical device
11. Connected to an electronic device that cannot be removed
12. Missing all or part of fingers or cuts/burns on pads of fingers
13. Long fingernails and unwilling to cut them and keep them cut for the duration of the study
14. Hand tremors or involuntary oscillations ("shaking") of the hands that prevents clear imaging

Additional exclusion criteria for control population:

Previous head trauma

Trial design

200 participants in 2 patient groups

Traumatic Brain Injury

Description:

Men and women ages 18-65 with suspected acute head trauma within 24-72hrs. of presentation, scoring a 3-15 on initial evaluation on GCS scale.

Control

Description:

Men and women ages 18-65 with no history of head trauma and a score of 15 on the GCS scale.

Treatment:

Device: ClearView Scanning