Methylphenidate for Attention Problems After Pediatric TBI

Study Overview
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Brief Summary
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Traumatic Brain Injury (TBI) - methylphenidate treatment

Detailed Description
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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).

Official Title
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Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)

Conditions
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TBI, Traumatic Brain Injury, ADHD

Intervention / Treatment
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* Drug: Methylphenidate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br>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. | Drug: Methylphenidate<br> <br> * Other names: Concerta;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS) | 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. | Reported at End of Methylphenidate Arm (Week 4 or 8) | 
| Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF) | 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. | Reported at End of Methylphenidate Arm (Week 4 or 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI) | 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. | Reported at End of Methylphenidate Arm (Week 4 or 8) | 
| Teacher Outcome Measure | Used to assess child behavior. | January 1, 2014 - July 20, 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, traumatic brain injury, ADHD, methylphenidate, Concerta, attention problems