Methylphenidate for Attention Problems After Pediatric TBI

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 4

Conditions: Traumatic Brain Injury; TBI; ADHD

Treatments: Drug: Methylphenidate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01933217

1K23HD074683-01A1

Details and patient eligibility

About

Traumatic Brain Injury (TBI) - methylphenidate treatment

Full description

The objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and attentional control to treatment efficacy. The proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems >6 months after moderate to severe TBI into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Enrollment: 26 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between ages of 6-17
• Sustained Moderate to Severe TBI
• TBI occurred at least 6 months prior to beginning the study
• TBI occurred no earlier than 5 years of age
• Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale

Exclusion criteria

• History of developmental disability or mental retardation
• Current active participation in ADHD-related behavioral intervention
• History of psychiatric condition requiring an inpatient admission in past 12 months
• Actively taking medications with a contraindication to Concerta that cannot be discontinued
• Current use of stimulant medication or ADHD specific medications that cannot be discontinued
• Non-blunt head injury
• Family history of arrhythmia
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Methylphenidate

Experimental group

Description:

The study medication will consist of identical capsules filled Concerta® over-encapsulated to preserve double-blinding. The weekly dosages will be low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial. Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.

Treatment:

Drug: Methylphenidate

Placebo

Placebo Comparator group

Description:

The study medication will consist of identical capsules filled with an inert white power (placebo). Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.

Treatment:

Drug: Placebo