Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children

NCT04540445 | Unknown

• 1 other identifier: 1909112
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather information and compare the potential use of pupillometry to identify concussions and post concussive syndrome with standard age appropriate assessments. The study will compare concussed pediatric patients 5-17 years of age recruited from the emergency department within 72 hours following injury with age and gender matched non-concussed pediatric patients recruited from primary care clinics. Assessment of both concussed and non-concussed subjects will take place at the initial enrollment visit and will be repeated at 1-2 weeks for the concussed subjects and at 12-14 weeks for both groups.

Conditions

Brain Concussion; Reflex, Pupillary; Post-Concussion Syndrome; Brain Injuries, Traumatic

Keywords

pupillometry; concussion; traumatic brain injury; post-concussion syndrome

Outcome Measures

Primary Outcomes (5)

• The association between NPi®-200 pupillometer measurements (including variables such as size, latency, constriction velocity, dilation velocity, etc.) and concussed/control status over time.

  NPi®-200 pupillometer is a hand-held portable infrared device which provides quantitative pupillary measurements by taking 30 pictures per second of the pupil's response to light stimulus for a duration of 3 seconds. A patient's pupil measurement (including variables such as size, latency, constriction velocity, dilation velocity, etc.) is compared against a normative model of pupil reaction to light and automatically graded by the Neurological Pupil Index (NPi™) on a scale of 0 to 5. Pupillary measurements will be obtained for the right and left eye.

  For concussed subjects: the first measurement will be within 72 hours of sustaining injury, then repeated at 1-2 weeks and at 12-14 weeks post injury. For control subjects: the first measurement will be at enrollment and repeated at 12-14 weeks.

• The association between the NeurOptics PLR-3000 pupillometer measurements (including variables such as size, latency, constriction velocity, dilation velocity, etc.) and concussed/control status over time.

  The NeurOptics PLR-3000 pupillometer is a hand-held portable infrared device which provides quantitative pupillary measurements by taking 30 pictures per second of the pupil's response to light stimulus for a duration of 6 seconds. Pupillary data, such as constriction velocity, latency, pupil size before and after the reflex, dilation velocity, time to reach 75% of initial resting diameter after constriction (T75) are calculated automatically at the end of each measurement. Pupillary measurements will be obtained for the right and left eye.

  For concussed subjects: the first measurement will be within 72 hours of sustaining injury, then repeated at 1-2 weeks and at 12-14 weeks post injury. For control subjects: the first measurement will be at enrollment and repeated at 12-14 weeks.

• The association between the Post-Concussion Symptom Inventory (PCSI) & Post-Concussion Symptom Scale (PCSS) and concussed/control status over time.

  PCSI assesses post-concussion symptoms based on patient and parent/teacher report. This inventory focuses on four areas that may be affected after concussion: cognitive, emotional, physical, and sleep. There are age-specific forms available for children between 5-7 years old, 8-12 years old, and 13-18 years old. This tool has been found to have moderate to high (0.62 to 0.84) inter-rater reliability for child reports and internal consistency across the three reports. PCSS is also a self-reported assessment of post-concussion symptoms. This report, which is part of the widely used Sport Concussion Assessment Tool (SCAT) Versions 3 and 5 and Immediate Post-Concussion Assessment and Cognitive Test (ImPACT), quantifies symptom severity (rank 22 different possible post-concussion symptoms on 7 point Likert scale). Similar to the PCSI, the PCSS includes symptoms from four areas: cognitive, emotional, physical, and sleep.

  For concussed subjects: the first measurement will be within 72 hours of sustaining injury, then repeated at 1-2 weeks and at 12-14 weeks post injury. For control subjects: the first measurement will be at enrollment and repeated at 12-14 weeks.

• The association between the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT®) & ImPACT® Pediatric assessment and concussed/control status over time.

  ImPACT® and ImPACT® Pediatric will both be used in this study. ImPACT® is a computerized data collection and neuropsychological testing tool commonly used for baseline and post-injury testing in athletes (12-59 years of age) at risk for sports-related concussion. Subjects participate in neuropsychological tests which assess attention, verbal memory, visual memory, visual processing speed, and reaction times. ImPACT® will be used to evaluate study patients ≥12 years old. ImPACT® Pediatric is an examiner-administered iOS-based battery of neuropsychological tests designed to measure neurocognitive functioning in children ages 5-11. ImPACT® Pediatric is administered on an iPad and is a neurocognitive test for management of pediatric concussions. ImPACT® Pediatric will be used to evaluate patients \< 12 years old. Outcome variables will be obtained from ImPACT® and include data to evaluate: verbal memory, visual memory, visual processing speed, and reaction time.

  For concussed subjects: the first measurement will be within 72 hours of sustaining injury, then repeated at 1-2 weeks and at 12-14 weeks post injury. For control subjects: the first measurement will be at enrollment and repeated at 12-14 weeks.

• The association between the Balance Error Scoring System (BESS) scores and concussed/control status over time.

  The Balance Error Scoring System (BESS) provides an objective score for a patient's postural stability. The patient is instructed to stand in three different stances, first on a solid surface and then a foam surface, for 20 seconds each. The examiner records the number of errors, as predefined by the scoring system, during each stance. The maximum score is 60 and a higher score correlates with worsening postural stability. This test has demonstrated good test-rest reliability (0.87-0.97 intraclass correlations), low to moderate sensitivity (0.34 to 0.64), and high specificity (0.91). Sensitivity is increased when this test is used in conjunction with a graded symptom checklist.

  For concussed subjects: the first measurement will be within 72 hours of sustaining injury, then repeated at 1-2 weeks and at 12-14 weeks post injury. For control subjects: the first measurement will be at enrollment and repeated at 12-14 weeks.

Study Arms (2)

Concussed Cohort

The concussed cohort will consist of children ages 5-17 diagnosed with a concussion within 72 hours following injury and recruited from a pediatric emergency department.

Other: Pupillary Assessment

Healthy Matched Controls

The healthy matched control cohort consists of children 5-17, who are age and gender matched to concussed subjects who will be recruited from affiliated pediatric primary care and adolescent clinics.

Other: Pupillary Assessment

Interventions

Pupillary Assessment OTHER

Pupillary assessment with handheld pupillometer

Also known as: NeurOptics PLR-3000, NeurOptics NPi®-200

Concussed Cohort; Healthy Matched Controls

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of concussed patients ages 5-17 presenting at a pediatric emergency department within 72 hours following concussion and healthy controls that are age and gender matched to concussed subjects recruited from affiliated primary care and adolescent clinics.

You may qualify if:

• Males or females ≥ 5 to \< 18 years of age
• Patients presenting to Pediatric Emergency Department with a concussion within 72 hours following injury. Concussion will be defined as the presence of the following criteria: Post injury patient reported symptoms on an age-appropriate graded-symptom checklist that meets the borderline to extremely high threshold (sex and age adjusted)
• Age and gender matched healthy controls recruited and evaluated through Primary Care (Orange Ambulatory) and Adolescent Clinics

You may not qualify if:

• Lower extremity deficiency or injury
• History of cognitive deficiencies
• History of ≥ 3 prior concussions
• History of attention deficit disorder
• Previously diagnosed concussion within the past year
• History of intracranial disease
• History of unresolved strabismus, diplopia, amblyopia
• History of unresolved cranial nerve III, IV or VI palsy
• History of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption
• History of unresolved extensive corneal surgery or scarring
• Lack of two functional eyes
• Unresolved oculo-motor dysfunctions
• Obvious intoxication or impairment that limits ability to participate
• Imaging abnormality (i.e. fracture or bleed)
• Color blindness OR failing the Ishihara screening for color blindness

Sponsors & Collaborators

• Children's Hospital of Orange County: lead
• NeurOptics Inc.: collaborator

Study Sites (1)

CHOC Children's

Orange, California, 92868, United States

RECRUITING

Related Publications (21)

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  BACKGROUND

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Related Links

• Biodex Balance Assessment for Concussion Management.

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Theodore Heyming, MD

  CHOC Children's Hospital of Orange County

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodore Heyming, MD

CONTACT

714-543-8911; theyming@choc.org

Jennifer Hayakawa, DNP

CONTACT

714-509-9339; jhayakawa@choc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: September 7, 2020
• Study Start: March 11, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)