Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery

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.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Childrens Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Moderate to severe traumatic brain injury

Treatment and study plan

Methylphenidate

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

Murray Fellowship

Registry information

Important dates

First posted: May 3, 2002
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed