Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)
研究概览
简要总结
Traumatic Brain Injury (TBI) - methylphenidate treatment
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Methylphenidate (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)
时间窗: 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)
时间窗: 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.
次要结局
- 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))
- Teacher Outcome Measure(January 1, 2014 - July 20, 2017)