Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540445
Status:
UNKNOWN
Last Update Posted:
2022-03-11
First Post:
2020-02-27
Brief Title:
Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children
Sponsor:
Childrens Hospital of Orange County
Organization:
Childrens Hospital of Orange County
Study Overview
Official Title:
Utility of Pupillary Metrics in Diagnosis and Management of Concussion in Children
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 playduty 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 providers Trained personnel performing follow-up assessments will use established clinical criteria to notify appropriate healthcare provider andor 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
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 providers Trained personnel performing follow-up assessments will use established clinical criteria to notify appropriate healthcare provider andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None