- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02858544
Concussion in Motor Vehicle Accidents: The Concussion Identification Index (CIDI)
Study Overview
Status
Conditions
- Brain Injuries
- TBI (Traumatic Brain Injury)
- Motor Vehicle Accidents
- Brain Concussion
- Brain Contusion
- Traumatic Brain Injury With Brief Loss of Consciousness
- Cerebral Concussion
- Accidents, Traffic
- Traumatic Brain Injury With Loss of Consciousness
- Traffic Accidents
- Cortical Contusion
- Concussion Mild
- Traumatic Brain Injury With no Loss of Consciousness
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Springfield, Massachusetts, United States, 01105
- Clionsky Neuro Systems, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation - Concussion Identification Index score with ImPACT test score
Time Frame: Within 90 days of the accident
|
Within 90 days of the accident
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Within 90 days of the accident
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mitchell I Clionsky, Ph.D, Clionsky Neuro Systems Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Craniocerebral Trauma
- Trauma, Nervous System
- Consciousness Disorders
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Unconsciousness
- Brain Concussion
- Contusions
- Brain Contusion
Other Study ID Numbers
- C-MVA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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