Concussion in Motor Vehicle Accidents: The Concussion Identification Index

Clionsky Neuro Systems Inc.1,790 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,790

Conditions

Motor Vehicle Accidents TBI (Traumatic Brain Injury)Brain Contusion Brain Injuries Cortical Contusion Concussion Mild

Interventions

The Concussion Identification IndexOTHER

Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms

ImPACTOTHER

Patient- completed computerized neurocognitive test battery

Eligibility

Sex: ALLMin age: 10 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Correlation - Concussion Identification Index score with ImPACT test score

Time frame: Within 90 days of the accident

Secondary Outcomes

Patient-completed one page questionnaire

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.