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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Concussion Identification Index | Other | Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation - Concussion Identification Index score with ImPACT test score | Within 90 days of the accident |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell I Clionsky, Ph.D | Clionsky Neuro Systems Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clionsky Neuro Systems, Inc. | Springfield | Massachusetts | 01105 | United States |
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| ImPACT | Other | Patient- completed computerized neurocognitive test battery |
|
| Within 90 days of the accident |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D000070624 | Brain Contusion |
| D001930 | Brain Injuries |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003288 | Contusions |
| D014949 | Wounds, Nonpenetrating |
| D016489 | Head Injuries, Closed |
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