Motor Vehicle AccidentsCIDINCT02858544
Concussion in Motor Vehicle Accidents: The Concussion Identification Index
An observational study of Motor Vehicle Accidents and TBI (Traumatic Brain Injury), run by Clionsky Neuro Systems Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Motor Vehicle Accidents, TBI (Traumatic Brain Injury), Brain Contusion
- What is being tested?
- The Concussion Identification Index and ImPACT
- How many people
- 1,790 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Patients injured in a motor-vehicle related accident
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clionsky Neuro Systems, Inc.
Springfield, Massachusetts, 01105
About this study
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.
Read the 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.
- Conditions
- Motor Vehicle Accidents, TBI (Traumatic Brain Injury), Brain Contusion, Brain Injuries, Cortical Contusion, Concussion Mild
- Being tested
- The Concussion Identification Index, ImPACT
- Keywords
- Mild traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Contusion, Brain Injuries, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Concussion Identification IndexOther
Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms
ImPACTOther
Patient- completed computerized neurocognitive test battery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The Concussion Identification Index; Other: 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. Receives: Other: The Concussion Identification Index; Other: ImPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation - Concussion Identification Index score with ImPACT test score
Measured: Within 90 days of the accident
Secondary outcomes (1)
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.
Measured: Within 90 days of the accident
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Vehicle AccidentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clionsky Neuro Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell I Clionsky, Ph.D, Principal investigator, Clionsky Neuro Systems Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858544
- Sponsor's protocol ID
- C-MVA
- Acronym
- CIDI
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concussion in Motor Vehicle Accidents: The Concussion Identification Index
- ClinicalTrials.gov ID
- NCT02858544
- Acronym / sponsor ID
- CIDI / C-MVA
- Conditions
- Motor Vehicle Accidents, TBI (Traumatic Brain Injury), Brain Contusion, Brain Injuries, Cortical Contusion, Concussion Mild
- Keywords
- Mild traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,790 participants (actual)
- Lead sponsor
- Clionsky Neuro Systems Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 - Validation Group | – | Other: The Concussion Identification Index, Other: ImPACTn=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 | – | Other: The Concussion Identification Index, Other: ImPACTn=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. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Patients injured in a motor-vehicle related accident
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Concussion Identification IndexPatient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms | Other | Group 2 - Cross Validation Group, Group1 - Validation Group |
| ImPACTPatient- completed computerized neurocognitive test battery | Other | Group 2 - Cross Validation Group, Group1 - Validation Group |
Primary outcome
Correlation - Concussion Identification Index score with ImPACT test score
Time frame: Within 90 days of the accident
1 secondary outcome
Patient-completed one page questionnaire
Time frame: Within 90 days of the accident
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell I Clionsky, Ph.D principal investigator
Clionsky Neuro Systems Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Vehicle Accidents and TBI (Traumatic Brain Injury), run by Clionsky Neuro Systems Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation - Concussion Identification Index score with ImPACT test score (time frame: Within 90 days of the accident). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.