Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery

This study has been completed.
Sponsor:
Collaborator:
Murray Fellowship
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00035139
First received: May 2, 2002
Last updated: June 23, 2005
Last verified: December 2003
  Purpose

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.


Condition Intervention Phase
Brain Injuries
Drug: methylphenidate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

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

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Moderate to severe traumatic brain injury

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035139

Locations
United States, Pennsylvania
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Murray Fellowship
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00035139     History of Changes
Other Study ID Numbers: NCRR-M01RR00240-1783
Study First Received: May 2, 2002
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
pediatric traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014