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
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
Safety Progress
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: DeviceControl Participants
Device
ActiveComparator Group · 1 Intervention: Diagnostic test · Intervention Types: DeviceTreatment
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
- Collins, Michael W., Anthony P. Kontos, David O. Okonkwo, Jon Almquist, Julian Bailes, Mark Barisa, Jeffrey Bazarian, et al.. 2016. “Statements of Agreement from the Targeted Evaluation and Active Management (TEAM) Approaches to Treating Concussion Meeting Held in Pittsburgh, October 15-16, 2015”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/neu.0000000000001447.
- Hoffer, Michael E., Carey Balaban, Mikhaylo Szczupak, James Buskirk, Hillary Snapp, James Crawford, Sean Wise, et al.. 2017. “The Use of Oculomotor, Vestibular, and Reaction Time Tests to Assess Mild Traumatic Brain Injury (mtbi) over Time”. Laryngoscope Investigative Otolaryngology. Wiley. doi:10.1002/lio2.74.
- Balaban, Carey, Michael E. Hoffer, Mikhaylo Szczupak, Hillary Snapp, James Crawford, Sara Murphy, Kathryn Marshall, Constanza Pelusso, Sean Knowles, and Alex Kiderman. 2016. “Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury”. Edited by Damir Janigro. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0162168.
- Mucha, Anne, Michael W. Collins, R.J. Elbin, Joseph M. Furman, Cara Troutman-Enseki, Ryan M. DeWolf, Greg Marchetti, and Anthony P. Kontos. 2014. “A Brief Vestibular/ocular Motor Screening (VOMS) Assessment to Evaluate Concussions”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546514543775.
- Kontos, A.P. and M.W. Collins, Concussion: A clinical profile approach to assessment and treatment. 2018, Washington, DC: American Psychological Association Books
- Collins MW, Kontos AP, Okonkwo DO, Almquist J, Bailes J, Barisa M, Bazarian J, Bloom OJ, Brody DL, Cantu R, Cardenas J, Clugston J, Cohen R, Echemendia R, Elbin RJ, Ellenbogen R, Fonseca J, Gioia G, Guskiewicz K, Heyer R, Hotz G, Iverson GL, Jordan B, Manley G, Maroon J, McAllister T, McCrea M, Mucha A, Pieroth E, Podell K, Pombo M, Shetty T, Sills A, Solomon G, Thomas DG, Valovich McLeod TC, Yates T, Zafonte R. Statements of Agreement From the Targeted Evaluation and Active Management (TEAM) Approaches to Treating Concussion Meeting Held in Pittsburgh, October 15-16, 2015. Neurosurgery. 2016 Dec;79(6):912-929. doi: 10.1227/NEU.0000000000001447.
- Carey Balaban 2020. "Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04372797.
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Conditions
Cancer Related
Treatments