Motor Vehicle Accidents, TBI (Traumatic Brain Injury), Brain Contusion, Brain Injuries, Cortical Contusion, Concussion Mild, Cerebral Concussion, Brain Concussion, Accidents, Traffic, Traffic Accidents, Traumatic Brain Injury With Brief Loss of Consciousness, Traumatic Brain Injury With no Loss of Consciousness, Traumatic Brain Injury With Loss of Consciousness
Conditions
Keywords
Mild traumatic brain injury
Brief summary
The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment for concussion.
Detailed description
This Phase 2 study, Concussion in Motor Vehicle Accidents - The Concussion Identification Index (CIDI), focuses on the psychometric properties of the relationship between acute injury events, i.e. head impact, loss of consciousness (LOC), and post-traumatic amnesia (PTA), commonly reported post-crash signs and symptoms, and neurocognitive outcomes. Cohort 1 is the validation group and will be used to confirm the optimal cut-off score of the Concussion Identification Index (CIDI) with the score on the ImPACT. Cohort 2 is the cross-validation group.
Interventions
OTHERThe Concussion Identification Index
Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms
OTHERImPACT
Patient- completed computerized neurocognitive test battery
Sponsors
Clionsky Neuro Systems Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients injured in a motor-vehicle related accident
Exclusion criteria
* Age younger than 10 years old or older than 60 years of age * Patients who presented for initial evaluation of injuries greater than 90 days after MVA occurred * Patients who declined to take a computerized neurocognitive test battery * Patients who were not fluent in either English or Spanish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation - Concussion Identification Index score with ImPACT test score | Within 90 days of the accident |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-completed one page questionnaire | Within 90 days of the accident | The questionnaire is divided into two parts: The Injury Characteristics section: asks for a yes-no indication of whether 5 concussion-associated events/injuries occurred: striking the head, whiplash, loss of consciousness, being dazed, or having post-traumatic amnesia; and, whether or not the patient had already been given a diagnosis of concussion. The Concussive Symptoms section asks the patient to rate on a scale of 0-3 the presence and severity of 10 cognitive and emotional symptoms associated with a post-concussion diagnosis. The total numeric value for each patient is reported as an indexed score. |
Countries
United States
Outcome results
None listed