Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children
NCT ID: NCT04540445
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
130 participants
OBSERVATIONAL
2020-03-11
2022-12-31
Brief Summary
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Detailed Description
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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 proposed study design is prospective, longitudinal case-control consisting of two distinct cohorts: concussed participants and healthy control participants. All concussion management decisions will be determined independent of the study by the healthcare provider(s). Trained personnel performing follow-up assessments will use established clinical criteria to notify appropriate healthcare provider and/or study team member of any clinical concerns or unanticipated events.
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 affiliated primary care and adolescent 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. Age appropriate assessment will include the Post-Concussion Symptom Inventory (PCSI), Post-Concussion Symptom Scale (PCSS), pupillometry, Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), and Balance Error Scoring System (BESS).
The primary objectives are to examine the acute (\<72 hours), subacute (1-2 week), and long-term (12-14 weeks post-injury) longitudinal association among pupillary metrics, standardized neurocognitive tests, and objective balance assessment in pediatric patients with concussion versus controls. The secondary objectives are to evaluate the effectiveness of pupillometer data as an objective biomarker to aid in the identification of concussion and post-concussive syndrome in children. Results will generate new knowledge regarding the clinical utility of pupillometers in this patient population. We will explore the period that best differentiates concussion and controls.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Pupillary Assessment
Pupillary assessment with handheld pupillometer
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.
Pupillary Assessment
Pupillary assessment with handheld pupillometer
Interventions
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Pupillary Assessment
Pupillary assessment with handheld pupillometer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Age and gender matched healthy controls recruited and evaluated through Primary Care (Orange Ambulatory) and Adolescent Clinics
Exclusion Criteria
2. History of cognitive deficiencies
3. History of ≥ 3 prior concussions
4. History of attention deficit disorder
5. Previously diagnosed concussion within the past year
6. History of intracranial disease
7. History of unresolved strabismus, diplopia, amblyopia
8. History of unresolved cranial nerve III, IV or VI palsy
9. History of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption
10. History of unresolved extensive corneal surgery or scarring
11. Lack of two functional eyes
12. Unresolved oculo-motor dysfunctions
13. Obvious intoxication or impairment that limits ability to participate
14. Imaging abnormality (i.e. fracture or bleed)
15. Color blindness OR failing the Ishihara screening for color blindness
16. Unable to come in for follow-up visits
5 Years
17 Years
ALL
Yes
Sponsors
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NeurOptics Inc.
INDUSTRY
Children's Hospital of Orange County
OTHER
Responsible Party
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Theodore Heyming
Principal Investigator
Principal Investigators
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Theodore Heyming, MD
Role: PRINCIPAL_INVESTIGATOR
CHOC Children's Hospital of Orange County
Locations
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CHOC Children's
Orange, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Schutzman SA, Greenes DS. Pediatric minor head trauma. Ann Emerg Med. 2001 Jan;37(1):65-74. doi: 10.1067/mem.2001.109440.
Bazarian JJ, McClung J, Shah MN, Cheng YT, Flesher W, Kraus J. Mild traumatic brain injury in the United States, 1998--2000. Brain Inj. 2005 Feb;19(2):85-91. doi: 10.1080/02699050410001720158.
Wortzel HS, Granacher RP Jr. Mild Traumatic Brain Injury Update: Forensic Neuropsychiatric Implications. J Am Acad Psychiatry Law. 2015 Dec;43(4):499-505.
Zaloshnja E, Miller T, Langlois JA, Selassie AW. Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005. J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400. doi: 10.1097/01.HTR.0000341435.52004.ac.
McCrory P, Meeuwisse W, Dvorak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, Feddermann-Demont N, Giza CC, Guskiewicz KM, Herring S, Iverson GL, Johnston KM, Kissick J, Kutcher J, Leddy JJ, Maddocks D, Makdissi M, Manley GT, McCrea M, Meehan WP, Nagahiro S, Patricios J, Putukian M, Schneider KJ, Sills A, Tator CH, Turner M, Vos PE. Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017 Jun;51(11):838-847. doi: 10.1136/bjsports-2017-097699. Epub 2017 Apr 26. No abstract available.
Papa L. Potential Blood-based Biomarkers for Concussion. Sports Med Arthrosc Rev. 2016 Sep;24(3):108-15. doi: 10.1097/JSA.0000000000000117.
Burke MJ, Fralick M, Nejatbakhsh N, Tartaglia MC, Tator CH. In search of evidence-based treatment for concussion: characteristics of current clinical trials. Brain Inj. 2015;29(3):300-5. doi: 10.3109/02699052.2014.974673. Epub 2014 Nov 10.
Bin Zahid A, Hubbard ME, Lockyer J, Podolak O, Dammavalam VM, Grady M, Nance M, Scheiman M, Samadani U, Master CL. Eye Tracking as a Biomarker for Concussion in Children. Clin J Sport Med. 2020 Sep;30(5):433-443. doi: 10.1097/JSM.0000000000000639.
Ciuffreda KJ, Joshi NR, Truong JQ. Understanding the effects of mild traumatic brain injury on the pupillary light reflex. Concussion. 2017 Aug 3;2(3):CNC36. doi: 10.2217/cnc-2016-0029. eCollection 2017 Nov.
Thiagarajan P, Ciuffreda KJ. Pupillary responses to light in chronic non-blast-induced mTBI. Brain Inj. 2015;29(12):1420-5. doi: 10.3109/02699052.2015.1045029. Epub 2015 Jul 16.
Walsh DV, Capo-Aponte JE, Beltran T, Cole WR, Ballard A, Dumayas JY. Assessment of the King-Devick(R) (KD) test for screening acute mTBI/concussion in warfighters. J Neurol Sci. 2016 Nov 15;370:305-309. doi: 10.1016/j.jns.2016.09.014. Epub 2016 Sep 11.
Anderson M, Elmer J, Shutter L, Puccio A, Alexander S. Integrating Quantitative Pupillometry Into Regular Care in a Neurotrauma Intensive Care Unit. J Neurosci Nurs. 2018 Feb;50(1):30-36. doi: 10.1097/JNN.0000000000000333.
Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
McNett M, Moran C, Janki C, Gianakis A. Correlations Between Hourly Pupillometer Readings and Intracranial Pressure Values. J Neurosci Nurs. 2017 Aug;49(4):229-234. doi: 10.1097/JNN.0000000000000290.
Voelker R. Eye-Tracking Test Approved to Help Diagnose Concussion. JAMA. 2019 Feb 19;321(7):638. doi: 10.1001/jama.2019.0509. No abstract available.
Covassin T, Elbin RJ 3rd, Stiller-Ostrowski JL, Kontos AP. Immediate post-concussion assessment and cognitive testing (ImPACT) practices of sports medicine professionals. J Athl Train. 2009 Nov-Dec;44(6):639-44. doi: 10.4085/1062-6050-44.6.639.
Iverson GL, Schatz P. Brief iPad-Based Assessment of Cognitive Functioning with ImPACT(R) Pediatric. Dev Neuropsychol. 2019 Jan-Feb;44(1):43-49. doi: 10.1080/87565641.2018.1545844. Epub 2018 Nov 22.
Howell DR, Osternig LR, Chou LS. Detection of Acute and Long-Term Effects of Concussion: Dual-Task Gait Balance Control Versus Computerized Neurocognitive Test. Arch Phys Med Rehabil. 2018 Jul;99(7):1318-1324. doi: 10.1016/j.apmr.2018.01.025. Epub 2018 Feb 16.
Bell DR, Guskiewicz KM, Clark MA, Padua DA. Systematic review of the balance error scoring system. Sports Health. 2011 May;3(3):287-95. doi: 10.1177/1941738111403122.
Capó-Aponte, JE, Urosevich TG, Walsh DV, Temme LA, & Tarbett AK. Pupillary light reflex as an objective biomarker for early identification of blast-induced mTBI. Journal of Spine S4:004, 2013.
Coronado VG, McGuire LC, Sarmiento K, Bell J, Lionbarger MR, Jones CD, Geller AI, Khoury N, Xu L. Trends in Traumatic Brain Injury in the U.S. and the public health response: 1995-2009. J Safety Res. 2012 Sep;43(4):299-307. doi: 10.1016/j.jsr.2012.08.011. Epub 2012 Aug 25.
Related Links
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Biodex Balance Assessment for Concussion Management.
Other Identifiers
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1909112
Identifier Type: -
Identifier Source: org_study_id
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