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 range18 Years – 50 Years

SexALL

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
✕. 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

What they're measuring

I-PAS Predictive Saccade Generation Score

Timeframe: 2 minutes

I-PAS Antisaccade Task Error Rate

Timeframe: 2 minutes

I-PAS Binocular Disparity Vergence Test

Timeframe: 3 minutes

I-PAS Optokinetic Slow Phase Gain Symmetry

Timeframe: 2 min

I-PAS Smooth Pursuit Velocity Gain Symmetry

Timeframe: 1 min

Vestibular/Ocular Motor Screening (VOMS) score

Timeframe: 5 minutes

Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)

Timeframe: 25 minutes

Automated Neuropsychological Assessment Measure (ANAM).

Timeframe: 20 minutes

Trial details

NCT IDNCT04372797

SponsorCarey Balaban

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials

Who can participate

Age range18 Years – 50 Years

SexALL

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
✕. 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

What they're measuring

I-PAS Predictive Saccade Generation Score

Timeframe: 2 minutes

I-PAS Antisaccade Task Error Rate

Timeframe: 2 minutes

I-PAS Binocular Disparity Vergence Test

Timeframe: 3 minutes

I-PAS Optokinetic Slow Phase Gain Symmetry

Timeframe: 2 min

I-PAS Smooth Pursuit Velocity Gain Symmetry

Timeframe: 1 min

Vestibular/Ocular Motor Screening (VOMS) score

Timeframe: 5 minutes

Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)

Timeframe: 25 minutes

Automated Neuropsychological Assessment Measure (ANAM).

Timeframe: 20 minutes