CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Immediate Post-concussion Assessment and Cognitive Testingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00715949
NCT00715949N/ACompleted

Neurocognitive Evaluation of Minor Traumatic Brain Injury in the Hospitalized Pediatric Population

Children's Hospital of Philadelphia·observational·Posted Jul 15, 2008·Updated May 4, 2015

In Brief

An observational study evaluating Immediate Post-concussion Assessment and Cognitive Testing for Mild Traumatic Brain Injury and Concussion. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Brain injuries from trauma are common in children, often resulting in death and disability. Most brain injuries are minor, yet their treatment can be challenging. Because there are many different scales used to characterize the severity of brain injury, there is no consensus regarding how to manage patients with minor brain injuries. Specifically, there is no agreement on recommendations regarding the safety of return to activities following injury. In young athletes with minor brain injuries (i.e. concussions) there is strong data suggesting that return to baseline neurologic function is often delayed by days or weeks. Children allowed to return to activities too soon may be at a higher risk for a second concussion, may delay recovery or, in rare cases, die. Researchers have designed a computer-based testing system (ImPACT©) to objectively test for neurologic deficits following injury. This test has been used primarily in athletes following a concussion but is also applicable to children with brain injuries from non-sports related traumas. We propose to utilize this testing in pediatric patients admitted to the hospital with minor brain injury. The test would be administered at the time of the hospitalization as well as in the outpatient trauma clinic at the time of routine follow up. The test would allow us to determine if there are neurologic deficits, potentially subclinical, in these brain injured patients and how quickly they recover from their injuries. If successful, the testing will likely be useful in other clinical settings such as the primary care office (e.g. pediatrician), specialty care office (e.g. sports medicine), or emergency room to determine if an injured child requires additional intervention.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 15, 2008
Enrollment StartDec 1, 2005
Primary CompletionDec 1, 2007
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.0 years ago

Interventions

Immediate Post-concussion Assessment and Cognitive Testingother

ImPACT© utilizes a battery of neurocognitive tests to assess neurologic deficits.