Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04186429
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2019-11-26
Brief Title:
Epigenetic Effects on Traumatic Brain Injury Recovery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Epigegenetic Influences on Neurobehavioral Recovery Following Pediatric Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
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:
EETR
Brief Summary:
Methylation of the brain-derived neurotrophic factor BDNF gene is involved in both the biological encoding of childhood adversity and neuroplasticity following traumatic brain injury TBI This research will characterize BDNF methylation during recovery from TBI in children and investigate this novel biomarker as a potential biological mechanism underlying the known association between childhood adversity and poorer neurobehavioral outcomes following TBI in childhood Findings from this research will contribute to an improved understanding of why some children display good recovery following TBI whereas many others suffer from chronic neurobehavioral impairments
Detailed Description:
Unexplained heterogeneity in outcomes following pediatric traumatic brain injury TBI is one of the most critical barriers to the development of effective prognostic tools and therapeutics The addition of personal biological factors to our prediction models may account for a significant portion of unexplained variance and advance the field towards precision rehabilitation medicine The overarching goal of the Epigenetic Effects on Pediatric Traumatic Brain Injury Recovery EETR study is to investigate an epigenetic biomarker involved in both childhood adversity and post-injury neuroplasticity to better understand heterogeneity in neurobehavioral outcomes following pediatric TBI The primary hypothesis is that childhood adversity will be associated with poorer neurobehavioral recovery in part through an epigenetically mediated reduction in brain-derived neurotrophic factor BDNF expression in response to TBI
EETR is an observational prospective longitudinal concurrent cohort study of children aged 3-18 years with either TBI n200 or orthopedic injury n100 recruited from the UPMC Childrens Hospital of Pittsburgh Participants complete study visits acutely and at 6- and 12-months post-injury Blood and saliva biosamples are collected at all time points-and CSF when available acutely-for epigenetic and proteomic analysis of BDNF Additional measures assess injury characteristics pre- and post-injury child neurobehavioral functioning childhood adversity and potential covariatesconfounders Analyses will characterize BDNF DNA methylation and protein levels over the recovery period and investigate this novel biomarker as a potential biological mechanism underlying the known association between childhood adversity and poorer neurobehavioral outcomes following pediatric TBI
EETR is an observational prospective longitudinal concurrent cohort study of children aged 3-18 years with either TBI n200 or orthopedic injury n100 recruited from the UPMC Childrens Hospital of Pittsburgh Participants complete study visits acutely and at 6- and 12-months post-injury Blood and saliva biosamples are collected at all time points-and CSF when available acutely-for epigenetic and proteomic analysis of BDNF Additional measures assess injury characteristics pre- and post-injury child neurobehavioral functioning childhood adversity and potential covariatesconfounders Analyses will characterize BDNF DNA methylation and protein levels over the recovery period and investigate this novel biomarker as a potential biological mechanism underlying the known association between childhood adversity and poorer neurobehavioral outcomes following pediatric TBI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K01HD097030-01A1 | NIH | None | httpsreporternihgovquickSearch1K01HD097030-01A1 |