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Completed

NCT Number: NCT02858544

Concussion in Motor Vehicle Accidents: The Concussion Identification Index

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.

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Key information

Conditions

Motor Vehicle Accidents Accidents, Traffic Brain Concussion Brain Contusion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cerebral Concussion Concussion Mild Contusions Cortical Contusion Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases TBI (Traumatic Brain Injury) Traffic Accidents Trauma, Nervous System Traumatic Brain Injury With Brief Loss of Consciousness Traumatic Brain Injury With Loss of Consciousness Traumatic Brain Injury With No Loss of Consciousness Wounds and Injuries Wounds, Nonpenetrating

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clionsky Neuro Systems, Inc.

Springfield, Massachusetts, 01105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Concussion Identification Index

Other

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

impact

Other

Patient- completed computerized neurocognitive test battery

Primary outcomes

  1. Correlation - Concussion Identification Index score with ImPACT test score

    Time frame: Within 90 days of the accident

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Clionsky Neuro Systems Inc.

Industry

Registry information

Acronym: CIDI

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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