Concussion in Motor Vehicle Accidents: The Concussion Identification Index
CIDI
1 other identifier
observational
1,790
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedAugust 8, 2016
August 1, 2016
2.6 years
August 2, 2016
August 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation - Concussion Identification Index score with ImPACT test score
Within 90 days of the accident
Secondary Outcomes (1)
Patient-completed one page questionnaire
Within 90 days of the accident
Study Arms (2)
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.
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.
Interventions
Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms
Patient- completed computerized neurocognitive test battery
Eligibility Criteria
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
You may qualify if:
- Patients injured in a motor-vehicle related accident
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clionsky Neuro Systems, Inc.
Springfield, Massachusetts, 01105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell I Clionsky, Ph.D
Clionsky Neuro Systems Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 8, 2016
Study Start
November 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 8, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share