Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)

NCT04372797 | Completed FDA Device

• 2 other identifiers: STUDY200200320011413765
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (11)

• I-PAS Predictive Saccade Generation Score

  First predictive saccade to target in a series. Range:1-24. A lower score is better.

  2 minutes

• I-PAS Antisaccade Task Error Rate

  Percent of pro-saccadic errors. Range: 0-100%. A lower score is better.

  2 minutes

• I-PAS Binocular Disparity Vergence Test

  Two factor discriminant function classifier for mTBI versus Control subjects

  3 minutes

• I-PAS Optokinetic Slow Phase Gain Symmetry

  Comparison of performance in the right and left direction. Range: 0-100%. Lower value is better

  2 min

• I-PAS Smooth Pursuit Velocity Gain Symmetry

  Comparison of performance in the right and left direction. Range: 0-100%. Lower value is better.

  1 min

• Vestibular/Ocular Motor Screening (VOMS) score

  Patients verbally rate changes in headache, dizziness, nausea and fogginess symptoms compared to their immediate pre-assessment state on a scale of 0 (none) to 10 (severe) following each of the following tasks: 1) smooth pursuit, 2) horizontal and vertical saccades, 3) convergence, 4) horizontal and vertical vestibular ocular reflex (VOR) and 5) visual motion sensitivity (VMS). A near convergence point is also measured. Lower scores are better on each component.

  5 minutes

• Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)

  ImPACT is a computerized neurocognitive test that includes six modules: 1) verbal memory, 2) design memory, 3) X's and O's, 4) symbol matching, 5) color matching, and 6) three letter memory (ImPACT Applications Inc.). These modules are used to form four composite scores: verbal and visual memory (%), visual motor processing speed (#), and reaction time (RT) (sec). The ImPACT also includes the Post-concussion Symptom Scale (PCSS), which is a 22-item self-reported symptom severity inventory of somatic, cognitive, affective and sleep-related symptoms. Both composite and item scores are used.

  25 minutes

• Automated Neuropsychological Assessment Measure (ANAM).

  ANAM is a computerized neurocognitive test that includes eight test modules: 1) code substitution delayed, 2) code substitution, 3) matching to sample, 4) mathematical processing, 5) procedural reaction time, 6) simple reaction time, 7) simple reaction time repeated, and 8) go/no go (ANAM v. 4.3; Vista Life Sciences). These modules are scored based on accuracy, speed, and throughput (accuracy/mean reaction time). Both composite and item scores are used

  20 minutes

• Dynamic Visual Acuity Test

  First, the lens-corrected static visual acuity will be assessed using a standard Snellen or LogMAR eye chart. The lowest line that all letters can be read will be recorded. For dynamic visual acuity, the patient will flex their head down 30 deg, then rotate their head in the yaw plane at a frequency of about 2 Hz and amplitude of 20-30 deg. A metronome will be used to set the frequency. Again, the lowest line that all letters can be read will be recorded. A loss of greater than 2 lines suggests an impaired vestibulo-ocular reflex.

  5 minutes

• Modified Balance Error Scoring System (mBESS)

  The BESS measures postural stability and consists of three stances including feet side by side, a tandem stance, and a single-leg stance on the non-dominant leg. The three stances are performed for 20 sec each on a firm surface. All stances are completed with eyes closed and with hands on the iliac crests. Errors include lifting hands off the iliac crests, opening the eyes, stepping, stumbling, or falling, moving the hip into more than a 30 degree of flexion or abduction, lifting the forefoot or heel, or remaining out of the testing position for more than 5 seconds. Each error equals 1 point, with higher scores indicating worse performance.

  5 minutes

• Neurobehavioral Symptom Inventory (NSI)

  The NSI is a 22-item (i.e. symptom) scale in which participants rate the severity of symptoms on a 5-point scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe) ranging from 0-60. Both composite and item scores will be analyzed.

  5 minutes

Secondary Outcomes (4)

• Visual Vertigo Analog Scale (VVAS)

  5 minutes

• Dizziness Handicap Inventory (DHI)

  5 minutes

• Behavioral Symptom Inventory-18 (BSI-18)

  5 minutes

• Pittsburgh Sleep Quality Index (PSQI)

  5 minutes

Study Arms (2)

Mild Traumatic Brain Injury Participants

EXPERIMENTAL

Males and females from 18-50 years of age who present to a recruitment site within 10 days of injury with a diagnosed concussion that meets all of the following criteria: 1) clear mechanism of injury (i.e., direct or indirect impact to head), 2) 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 3) neurosensory symptoms.

Device: Diagnostic test

Control Participants

ACTIVE COMPARATOR

Age- and sex-matched control subjects with minor, non-surgical injuries (e.g., sprains, strains) not requiring hospital admission and no history of mild traumatic brain injury will be recruited from the same study sites.

Device: Diagnostic test

Interventions

Diagnostic test DEVICE

A battery of oculomotor tests

Control Participants; Mild Traumatic Brain Injury Participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For the mTBI group, participants must present to a recruitment site within 10 days of injury with a diagnosed concussion that meets all of the following 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.
• For Control group, participants will have minor, non-surgical injuries (e.g., sprains, strains) not requiring hospital admission and no history of mTBI will be recruited from the same study sites.

You may not qualify if:

• 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
• Presence of severe aphasia
• History of diagnosed psychiatric disorder (e.g., schizophrenia)
• Documented neurological disorders (e.g., Epilepsy, stroke, dementia)
• Pregnancy (females will be asked if they are pregnant)
• Prior disorders of hearing and balance including:
• Meniere's disease
• Multiple sclerosis

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: collaborator
• Carey Balaban: lead
• University of Miami: collaborator
• United States Naval Medical Center, San Diego: collaborator

Study Sites (3)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

Location

Related Publications (5)

• 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.

  PMID: 27741219 BACKGROUND

• Kontos, A.P. and M.W. Collins, Concussion: A clinical profile approach to assessment and treatment. 2018, Washington, DC: American Psychological Association Books

  BACKGROUND

• Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.

  PMID: 25106780 BACKGROUND

• Balaban C, Hoffer ME, Szczupak M, Snapp H, Crawford J, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury. PLoS One. 2016 Sep 21;11(9):e0162168. doi: 10.1371/journal.pone.0162168. eCollection 2016.

  PMID: 27654131 BACKGROUND

• Hoffer ME, Balaban C, Szczupak M, Buskirk J, Snapp H, Crawford J, Wise S, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. The use of oculomotor, vestibular, and reaction time tests to assess mild traumatic brain injury (mTBI) over time. Laryngoscope Investig Otolaryngol. 2017 Apr 12;2(4):157-165. doi: 10.1002/lio2.74. eCollection 2017 Aug.

  PMID: 28894835 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Carey D Balaban, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: September 30, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)