Clinical Trial: Concussion in Motor Vehicle Accidents: The Concussion Identification Index
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Concussion in Motor Vehicle Accidents: The Concussion Identification Index
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 Summary:
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.
Sponsor: Clionsky Neuro Systems Inc.
Current Primary Outcome: Correlation - Concussion Identification Index score with ImPACT test score [ Time Frame: Within 90 days of the accident ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient-completed one page questionnaire [ Time Frame: 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.
Original Secondary Outcome: Same as current
Information By: Clionsky Neuro Systems Inc.
Dates:
Date Received: August 2, 2016
Date Started: November 2013
Date Completion:
Last Updated: August 3, 2016
Last Verified: August 2016
