NCT02858544

Concussion in Motor Vehicle Accidents: The Concussion Identification Index

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,790 (actual)
• Sponsor: Clionsky Neuro Systems Inc. · Industry
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	The Concussion Identification Index	Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms
OTHER	ImPACT	Patient- completed computerized neurocognitive test battery

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-08-08
• Last updated: 2016-08-08

Locations

1 site across 1 country: United States