Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain… (NCT04372797) | Clinical Trial Compass
CompletedNot Applicable
Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)
United States161 participantsStarted 2020-09-30
Plain-language summary
This study will establish the capability of a suite of conventional tests and the Neurolign Dx\_100 I-PAS goggle system to reliably and objectively detect mTBI in an acute setting when comparing individuals with mTBI to controls with minor injuries in a similarly stressful environment.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. clear mechanism of injury (i.e., direct or indirect impact to head),
. Glasgow Coma Scale= 13-15, 3) observed or reported signs (e.g., loss of consciousness, amnesia, or confusion) or symptoms (e.g., headache, dizziness, nausea), and
. neurosensory symptoms.
Exclusion criteria
. History of moderate to severe TBI characterized by any of the following:
. Penetrating head trauma
. GCS\< 13 at the time of injury
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a lot of eye movement and balance tests — like tracking eye movements and measuring how well I can see while moving — to assess mild TBI. Could any of these tools, like the I-PAS eye tracking or the Dynamic Visual Acuity Test, be used in my own evaluation, and what might the results tell us about my recovery?
2Since this trial has already been completed, has my doctor seen or reviewed any findings from it that might influence how they would diagnose or predict the course of my concussion?
3The trial measured both cognitive tests like ImPACT and ANAM alongside physical tests like balance and eye movement — does my care team currently use a combination of these approaches, or is there a gap in my assessment that the findings from this study might help fill?
4The trial tracked symptoms using the Neurobehavioral Symptom Inventory — how does my doctor currently monitor the kinds of symptoms this tool measures, like headaches, dizziness, or cognitive difficulties, and how would we know if my recovery is going off track?
5Because this was a diagnostic and prognostic study rather than a treatment trial, what do the results potentially mean for predicting how long my recovery might take, and is there anything in my specific situation that would change that outlook?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
I-PAS Predictive Saccade Generation Score
Timeframe: 2 minutes
2
I-PAS Antisaccade Task Error Rate
Timeframe: 2 minutes
3
I-PAS Binocular Disparity Vergence Test
Timeframe: 3 minutes
4
I-PAS Optokinetic Slow Phase Gain Symmetry
Timeframe: 2 min
5
I-PAS Smooth Pursuit Velocity Gain Symmetry
Timeframe: 1 min
6
Vestibular/Ocular Motor Screening (VOMS) score
Timeframe: 5 minutes
7
Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)
. Associated with LOC \> 30 minutes or amnesia \>24 hours
. Associated with subdural or epidural hemorrhage
. mTBI history
. mTBI Group - history of mTBI within the last 6 months or experiencing head injury symptoms immediately prior to the current head injury or history of 3 or more mTBIs
. Controls - No history of mTBI within the last 12 months and no presence of any mTBI-related symptoms at time of enrollment