Concussion in Motor Vehicle Accidents: The Concussion Identification Index

Brain Injuries Clinical Trial

— CIDI  

Official title:

Concussion in Motor Vehicle Accidents: The Concussion Identification Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858544
• Other study ID #: C-MVA
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 3, 2016
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Clionsky Neuro Systems Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1790
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Accidents, Traffic
• Brain Concussion
• Brain Contusion
• Brain Injuries
• Cerebral Concussion
• Concussion Mild
• Contusions
• Cortical Contusion
• Motor Vehicle Accidents
• TBI (Traumatic Brain Injury)
• Traffic Accidents
• Traumatic Brain Injury With Brief Loss of Consciousness
• Traumatic Brain Injury With Loss of Consciousness
• Traumatic Brain Injury With no Loss of Consciousness
• Unconsciousness
• Wounds and Injuries

Intervention

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
• ImPACT
Patient- completed computerized neurocognitive test battery

Locations

Country	Name	City	State
United States	Clionsky Neuro Systems, Inc.	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Clionsky Neuro Systems Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation - Concussion Identification Index score with ImPACT test score		Within 90 days of the accident	No
Secondary	Patient-completed one page questionnaire	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.	Within 90 days of the accident	No