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

Clionsky Neuro Systems

Status: Completed

Conditions: Brain Injuries; Traumatic Brain Injury With Brief Loss of Consciousness; Cortical Contusion; Brain Concussion; Cerebral Concussion; TBI (Traumatic Brain Injury); Brain Contusion; Concussion Mild; Motor Vehicle Accidents; Traumatic Brain Injury With no Loss of Consciousness; Accidents, Traffic; Traumatic Brain Injury With Loss of Consciousness; Traffic Accidents

Treatments: Other: ImPACT; Other: The Concussion Identification Index

Study type: Observational

Funder types: Industry

Identifiers

NCT02858544

C-MVA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,790 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,790 participants in 2 patient groups

Group1 - Validation Group

Description:

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.

Treatment:

Other: ImPACT

Other: The Concussion Identification Index

Group 2 - Cross Validation Group

Description:

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.

Treatment:

Other: ImPACT

Other: The Concussion Identification Index