Mild Traumatic Brain Injury Participants for Concussion

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ConcussionDiagnostic test - Device
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how well a set of common tests and a new brain injury detection system can identify people with mild brain injuries compared to those with only minor injuries.

Eligible Conditions
  • Concussion

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 4 Secondary · Reporting Duration: 25 minutes

1 min
I-PAS Smooth Pursuit Velocity Gain Symmetry
2 min
I-PAS Optokinetic Slow Phase Gain Symmetry
2 minutes
I-PAS Antisaccade Task Error Rate
I-PAS Predictive Saccade Generation Score
20 minutes
Automated Neuropsychological Assessment Measure (ANAM).
25 minutes
Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)
3 minutes
I-PAS Binocular Disparity Vergence Test
5 minutes
Behavioral Symptom Inventory-18 (BSI-18)
Dizziness Handicap Inventory (DHI)
Dynamic Visual Acuity Test
Modified Balance Error Scoring System (mBESS)
Neurobehavioral Symptom Inventory (NSI)
Pittsburgh Sleep Quality Index (PSQI)
Vestibular/Ocular Motor Screening (VOMS) score
Visual Vertigo Analog Scale (VVAS)

Trial Safety

Trial Design

2 Treatment Groups

Control Participants
1 of 2
Mild Traumatic Brain Injury Participants
1 of 2

Active Control

Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Mild Traumatic Brain Injury Participants · No Placebo Group · N/A

Mild Traumatic Brain Injury Participants
Device
Experimental Group · 1 Intervention: Diagnostic test · Intervention Types: Device
Control Participants
Device
ActiveComparator Group · 1 Intervention: Diagnostic test · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diagnostic test
2018
N/A
~1810

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 25 minutes

Who is running the clinical trial?

Carey BalabanLead Sponsor
Uniformed Services University of the Health SciencesFED
107 Previous Clinical Trials
91,201 Total Patients Enrolled
University of MiamiOTHER
795 Previous Clinical Trials
384,540 Total Patients Enrolled
United States Naval Medical Center, San DiegoFED
99 Previous Clinical Trials
25,328 Total Patients Enrolled
Carey D Balaban, PhDPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age 18 - 50 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The Control Group will consist of participants who have suffered minor, non-surgical injuries (e.g., sprains, strains) and have no history of mTBI
The clear mechanism of injury is either a direct or indirect impact to the head.
and 2) Glasgow Coma Scale score A person who experiences any of the following is likely to have a Glasgow Coma Scale score of 13-15: loss of consciousness, amnesia, or confusion; headache, dizziness, or nausea.
symptoms that affect the nervous system and senses.
References