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Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery

Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00035139
Enrollment
Unknown
Registered
2002-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

pediatric traumatic brain injury

Brief 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.

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

Interventions

DRUGmethylphenidate

Sponsors

Murray Fellowship
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

Moderate to severe traumatic brain injury

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026