Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Injuries
Intervention: methylphenidate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Center for Research Resources (NCRR)
Summary
Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among
children and young adults. Deficits in attention and memory are common and persist for years
after moderate or severe TBI. The similarity between these symptoms and those of children
with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of
methylphenidate in improving recovery of animals with brain injuries, support the need to
study methylphenidate effects in children with TBI. This investigation of methylphenidate in
children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different
dosages of methylphenidate on attention and reaction time when the medication is administered
to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to
improve the rate of recovery of cognitive, memory, and attentional skills in children with
TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.
Clinical Details
Official title: Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery
Study design: Treatment, Randomized, Placebo Control, Crossover Assignment, Efficacy Study
Detailed description:
During the first phase of the study which is of 8-days duration subjects will receive placebo
on some days and methylphenidate on others. During this phase of the study the effects of
the medication on children's performance on a computerized test of attention will be
assessed. Individuals who do not have significant methylphenidate side effects during the
first phase of the study will then participate in the second phase of the study. During the
second phase subjects will receive either methylphenidate or placebo for 8 weeks.
Neuropsychological measures of attention, memory, behavioral inhibition, cognitive
flexibility, and motor performance will be obtained at baseline and after the 8 week
medication trial in order to assess methylphenidate effects on the rate of recovery.
Recovery will also be assessed using an interview measure of adaptive behavior and cognitive
functioning. A stimulant medication side effect rating scale will be used to monitor for
common methylphenidate adverse effects throughout both phases of the study
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Moderate to severe traumatic brain injury
Locations and Contacts
Childrens Hospital Of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Additional Information
Last updated: June 23, 2005
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