Brain ConcussionNCT04540445
Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children
An observational study of Brain Concussion and Reflex, Pupillary, run by Children's Hospital of Orange County at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, Reflex, Pupillary, Post-Concussion Syndrome
- What is being tested?
- Pupillary Assessment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Unable to come in for follow-up visits
- In addition to the above exclusion criteria, healthy control participants will be excluded if they have a history of chronic disease.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CHOC Children's
Orange, California, 92868
Elizabeth Wallace, MPH, 714-509-4254 ext. 1-4254, ewallace@choc.org
Kellie Bacon, 714-509-8971, kellie.bacon@choc.org
About this study
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.
Read the detailed description
Traumatic brain injury (TBI) is the leading cause of disability and death in children. In both pediatric and adult populations, concussion is the most prevalent type of TBI and can result in persistent post-concussive symptoms. Early recognition and treatment of concussion is critical to the prevention of long-term sequelae and has recently become a national public-health priority. Comprehensive assessment and diagnosis of concussion commonly includes the use of a multimodal approach using a graded symptoms checklist, neurocognitive testing, and balance assessment. An objective biomarker to definitively diagnose concussion would revolutionize its management-allowing for accurate and immediate determination of return to play/duty, decreasing unnecessary exposure to radiation, and reducing the overall cost of care. Considering the paucity of evidence regarding the use of pupillary light reflex in concussed children and the lack of a biomarker for concussion, further examination of the use of objective pupillary metrics in this population is warranted.
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.
- Being tested
- Pupillary Assessment
- Keywords
- pupillometry, concussion, traumatic brain injury, post-concussion syndrome
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupillary AssessmentOther
Also called NeurOptics PLR-3000, NeurOptics NPi®-200
Pupillary assessment with handheld pupillometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pupillary Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start11 Mar 2020
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Collaborators
- NeurOptics Inc
- Responsible party
- Principal investigator, Theodore Heyming, Children's Hospital of Orange County
- Investigators
- Theodore Heyming, MD, Principal investigator, CHOC Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540445
- Sponsor's protocol ID
- 1909112
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available as data may be proprietary in nature.
Publications
Schutzman SA, Greenes DS. Pediatric minor head trauma. Ann Emerg Med. 2001 Jan;37(1):65-74. doi: 10.1067/mem.2001.109440.
PubMed 11145776Bazarian 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.
PubMed 15841752Wortzel HS, Granacher RP Jr. Mild Traumatic Brain Injury Update: Forensic Neuropsychiatric Implications. J Am Acad Psychiatry Law. 2015 Dec;43(4):499-505.
PubMed 26668228Zaloshnja 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.
PubMed 19033832McCrory 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.
PubMed 28446457Papa L. Potential Blood-based Biomarkers for Concussion. Sports Med Arthrosc Rev. 2016 Sep;24(3):108-15. doi: 10.1097/JSA.0000000000000117.
PubMed 27482776Burke 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.
PubMed 25383510Bin 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.
PubMed 30095503Ciuffreda 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.
PubMed 30202579Thiagarajan 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.
PubMed 26182230Walsh 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.
PubMed 27646958Anderson 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.
PubMed 29303836Chen 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.
PubMed 21748035McNett 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.
PubMed 28661946Voelker 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.
PubMed 30778585
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children
- ClinicalTrials.gov ID
- NCT04540445
- Acronym / sponsor ID
- 1909112
- Keywords
- pupillometry, concussion, traumatic brain injury, post-concussion syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Collaborators
- NeurOptics Inc
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traumatic brain injury (TBI) is the leading cause of disability and death in children. In both pediatric and adult populations, concussion is the most prevalent type of TBI and can result in persistent post-concussive symptoms. Early recognition and treatment of concussion is critical to the prevention of long-term sequelae and has recently become a national public-health priority. Comprehensive assessment and diagnosis of concussion commonly includes the use of a multimodal approach using a graded symptoms checklist, neurocognitive testing, and balance assessment. An objective biomarker to definitively diagnose concussion would revolutionize its management-allowing for accurate and immediate determination of return to play/duty, decreasing unnecessary exposure to radiation, and reducing the overall cost of care. Considering the paucity of evidence regarding the use of pupillary light reflex in concussed children and the lack of a biomarker for concussion, further examination of the use of objective pupillary metrics in this population is warranted.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussed Cohort | – | Other: Pupillary AssessmentThe 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. |
| Healthy Matched Controls | – | Other: Pupillary AssessmentThe 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupillary AssessmentAlso: NeurOptics PLR-3000, NeurOptics NPi®-200Pupillary assessment with handheld pupillometer | Other | Concussed Cohort, Healthy Matched Controls |
Primary outcome
The association between NPi®-200 pupillometer measurements (including variables such as size, latency, constriction velocity, dilation velocity, etc.) and concussed/control status over time.
Time frame: 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.
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.
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.
Time frame: 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 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.
The association between the Post-Concussion Symptom Inventory (PCSI) & Post-Concussion Symptom Scale (PCSS) and concussed/control status over time.
Time frame: 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.
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.
The association between the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT®) & ImPACT® Pediatric assessment and concussed/control status over time.
Time frame: 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.
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.
The association between the Balance Error Scoring System (BESS) scores and concussed/control status over time.
Time frame: 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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 11145776Schutzman SA, Greenes DS. Pediatric minor head trauma. Ann Emerg Med. 2001 Jan;37(1):65-74. doi: 10.1067/mem.2001.109440.
- Background: PubMed 15841752Bazarian 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.
- Background: PubMed 26668228Wortzel HS, Granacher RP Jr. Mild Traumatic Brain Injury Update: Forensic Neuropsychiatric Implications. J Am Acad Psychiatry Law. 2015 Dec;43(4):499-505.
- Background: PubMed 19033832Zaloshnja 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.
- Background: PubMed 28446457McCrory 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.
- Background: PubMed 27482776Papa L. Potential Blood-based Biomarkers for Concussion. Sports Med Arthrosc Rev. 2016 Sep;24(3):108-15. doi: 10.1097/JSA.0000000000000117.
- Background: PubMed 25383510Burke 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.
- Background: PubMed 30095503Bin 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.
- Background: PubMed 30202579Ciuffreda 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.
- Background: PubMed 26182230Thiagarajan 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.
- Background: PubMed 27646958Walsh 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.
- Background: PubMed 29303836Anderson 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available as data may be proprietary in nature.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Heyming, MD principal investigator
CHOC Children's Hospital of Orange County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and Reflex, Pupillary, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theodore Heyming, MD (714-543-8911, theyming@choc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between NPi®-200 pupillometer measurements (including variables such as size, latency, constriction velocity, dilation velocity, etc.) and concussed/control status over time. (time frame: 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540445, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.