Methylphenidate for Attention Problems After Pediatric TBI

Phase 4

Completed

• Conditions: Traumatic Brain Injury; TBI; ADHD
• Interventions: Drug: Placebo; Drug: Methylphenidate

• Registration Number: NCT01933217
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Traumatic Brain Injury (TBI) - methylphenidate treatment

Detailed 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).

Study Timeline

• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-09-02
• Study Start: 2013-11
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2020-03-19
• Status Verified: 2020-04
• Results First Submitted QC: 2020-06-02
• Last Update Submitted: 2020-06-02
• Results First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Methylphenidate	Methylphenidate	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.

Primary Outcome Measures

Name	Time	Method
Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)	Reported at End of Methylphenidate Arm (Week 4 or 8)	Changes in symptom ratings were assessed on the Vanderbilt ADHD parent rating scales (VADPRS). A measure of ADHD symptom severity (Total Symptom Score \[TSS\]) is computed by totaling the scores from items 1-18 (Inattentive +Hyperactive-impulse domains), with a rating of none=0, occasionally=1, often=2, very often=3, provided. Scores for inattentive and hyperactive-impulsive domains were generated by totaling the 9 symptoms in these domains, and a TSS was computed by totaling items across domains.
Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF)	Reported at End of Methylphenidate Arm (Week 4 or 8)	The Behavior Rating Inventory of Executive Functioning (BRIEF)-Parent was used to assess executive functioning behaviors. The global executive composite (GEC), behavior regulatory index (BRI), and metacognitive index (MI) T-scores were used, with higher scores reflecting poorer executive functioning. T-scores were normalized to 50 with a standard deviation of 10.

Secondary Outcome Measures

Name	Time	Method
Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)	Reported at End of Methylphenidate Arm (Week 4 or 8)	The Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI) has been designed for children 6-16:11 years of age and provides a measure of processing speed. For this index scale, the average score is 100 with a standard deviation of 15. Higher scores reflect better processing speed. One participant was administered the Wechsler Adult Intelligence Scale 4th Edition Processing Speed Index (WAIS-IV-PSI). All scores were included in the combined WISC/WAIS processing speed variable since both measures yield highly correlated standard scores.
Teacher Outcome Measure	January 1, 2014 - July 20, 2017	Used to assess child behavior.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States