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Concussion in Motor Vehicle Accidents: The Concussion Identification Index (CIDI)

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ClinicalTrials.gov Identifier: NCT02858544
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Clionsky Neuro Systems Inc.

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.

Condition or disease Intervention/treatment
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 Other: The Concussion Identification Index Other: ImPACT

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.


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Study Type : Observational
Actual Enrollment : 1790 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Concussion in Motor Vehicle Accidents: The Concussion Identification Index
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Group/Cohort Intervention/treatment
Group1 - Validation Group
n=890 patients seen and evaluated for possible concussion after a motor vehicle accident. Patients with qualifying scores on the Concussion Identification Index will also complete the ImPACT.
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

Group 2 - Cross Validation Group
n=900 patients seen and evaluated for possible concussion after a motor vehicle accident. Patients with qualifying scores on the Concussion Identification Index will also complete the ImPACT.
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




Primary Outcome Measures :
  1. Correlation - Concussion Identification Index score with ImPACT test score [ Time Frame: Within 90 days of the accident ]

Secondary Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Cohort 1 - Validation Group: Consecutive patients who presented for care between November 1, 2013 and December 31, 2014 at the MVA Center for Rehabilitation, a public health clinic in Springfield, MA which provides specialized outpatient auto accident treatment and rehabilitation

Cohort 2 - Cross Validation Group: Consecutive patients who presented for care between January 1, 2015 and June 30, 2016 at the MVA Center for Rehabilitation, a public health clinic in Springfield, MA

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858544


Locations
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United States, Massachusetts
Clionsky Neuro Systems, Inc.
Springfield, Massachusetts, United States, 01105
Sponsors and Collaborators
Clionsky Neuro Systems Inc.
Investigators
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Principal Investigator: Mitchell I Clionsky, Ph.D Clionsky Neuro Systems Inc.

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Responsible Party: Clionsky Neuro Systems Inc.
ClinicalTrials.gov Identifier: NCT02858544     History of Changes
Other Study ID Numbers: C-MVA
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Clionsky Neuro Systems Inc.:
Mild traumatic brain injury

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Unconsciousness
Contusions
Brain Contusion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms