Back to resultsMethylphenidate for Attention Problems After Pediatric TBI
Primary Purpose
Traumatic Brain Injury, TBI, ADHD
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring TBI, traumatic brain injury, ADHD, methylphenidate, Concerta, attention problems
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylphenidate
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Teacher Outcome Measure
Used to assess child behavior.
Full Information
NCT ID
NCT01933217
First Posted
July 15, 2013
Last Updated
June 2, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01933217
Brief Title
Methylphenidate for Attention Problems After Pediatric TBI
Official Title
Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, TBI, ADHD
Keywords
TBI, traumatic brain injury, ADHD, methylphenidate, Concerta, attention problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Concerta
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)
Description
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.
Time Frame
Reported at End of Methylphenidate Arm (Week 4 or 8)
Title
Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF)
Description
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.
Time Frame
Reported at End of Methylphenidate Arm (Week 4 or 8)
Secondary Outcome Measure Information:
Title
Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)
Description
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.
Time Frame
Reported at End of Methylphenidate Arm (Week 4 or 8)
Title
Teacher Outcome Measure
Description
Used to assess child behavior.
Time Frame
January 1, 2014 - July 20, 2017
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Kurowski, MS, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30169436
Citation
Kurowski BG, Epstein JN, Pruitt DW, Horn PS, Altaye M, Wade SL. Benefits of Methylphenidate for Long-Term Attention Problems After Traumatic Brain Injury in Childhood: A Randomized, Double-Masked, Placebo-Controlled, Dose-Titration, Crossover Trial. J Head Trauma Rehabil. 2019 Mar/Apr;34(2):E1-E12. doi: 10.1097/HTR.0000000000000432.
Results Reference
derived
Learn more about this trial
Methylphenidate for Attention Problems After Pediatric TBI
We'll reach out to this number within 24 hrs