Methylphenidate for Attention Problems After Pediatric TBI

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933217
• Other study ID #: 1K23HD074683-01A1
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: August 2016

Study information

• Verified date: April 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Traumatic Brain Injury (TBI) - methylphenidate treatment

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Brain Injuries
• Brain Injuries, Traumatic
• TBI
• Traumatic Brain Injury

Intervention

Drug:
• Methylphenidate

• Placebo

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Teacher Outcome Measure	Used to assess child behavior.	January 1, 2014 - July 20, 2017