Clinical trial NCT02858544: Concussion in Motor Vehicle Accidents: The Concussion Identification Index
Official title: Concussion in Motor Vehicle Accidents: The Concussion Identification Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Keywords: Mild traumatic brain injury
Lead sponsor: Clionsky Neuro Systems Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-08
Enrollment: 1790
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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 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.

Eligibility 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

Primary outcomes:
measure: Correlation - Concussion Identification Index score with ImPACT test score
timeFrame: Within 90 days of the accident
Secondary outcomes:
measure: Patient-completed one page questionnaire
timeFrame: Within 90 days of the accident
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Clionsky Neuro Systems, Inc.
state: Massachusetts
Study officials:
affiliation: Clionsky Neuro Systems Inc.
name: Mitchell I Clionsky, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: