An observational study in Motor Vehicle Accidents, TBI (Traumatic Brain Injury) and Brain Contusion, sponsored by Clionsky Neuro Systems Inc.. Completed at 1 site in United States. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-08-08.
Sponsored by Clionsky Neuro Systems Inc. · Observational
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.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's enrollment of 1,790 is above the median of 149 across 166 observational studies indexed under Brain Concussion.
Browse Brain Concussion studies →Clionsky Neuro Systems Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Brain Concussion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Injuries, Traumatic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: The Concussion Identification Index · Other: ImPACT
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.
Other: The Concussion Identification Index · Other: 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
Correlation - Concussion Identification Index score with ImPACT test score
Time frame: Within 90 days of the accident
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.
Time frame: Within 90 days of the accident
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Nov 2013, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Clionsky Neuro Systems Inc.