CompletedNot Applicable

Epigenetic Effects on Traumatic Brain Injury Recovery

United States401 participantsStarted 2017-07-01

Plain-language 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.

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

hospitalized overnight for a non-penetrating complicated mild to severe TBI as defined by the lowest post-resuscitation Glasgow Coma Scale (GCS) score or orthopedic injury.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIH Toolbox Cognition Battery (NIHTB-CB)

Timeframe: 6 months post-injury

NIH Toolbox Cognition Battery (NIHTB-CB)

Timeframe: 12 months post-injury

Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) or Preschool Version (BRIEF-P)

Timeframe: 6 months post-injury

Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) or Preschool Version (BRIEF-P)

Timeframe: 12 months post-injury

Strengths and Difficulties Questionnaire

Timeframe: 6 months post-injury

Strengths and Difficulties Questionnaire

Timeframe: 12 months post-injury

Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

Timeframe: 6 months post-injury

Trial details

NCT IDNCT04186429

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-31

View on ClinicalTrials.gov More Traumatic Brain Injury trials

Plain-language summary

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

hospitalized overnight for a non-penetrating complicated mild to severe TBI as defined by the lowest post-resuscitation Glasgow Coma Scale (GCS) score or orthopedic injury.

What they're measuring

NIH Toolbox Cognition Battery (NIHTB-CB)

Timeframe: 6 months post-injury

NIH Toolbox Cognition Battery (NIHTB-CB)

Timeframe: 12 months post-injury

Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) or Preschool Version (BRIEF-P)

Timeframe: 6 months post-injury

Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) or Preschool Version (BRIEF-P)

Timeframe: 12 months post-injury

Strengths and Difficulties Questionnaire

Timeframe: 6 months post-injury

Strengths and Difficulties Questionnaire

Timeframe: 12 months post-injury

Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

Timeframe: 6 months post-injury