Phase 4
Completed N=26
Methylphenidate for Attention Problems After Pediatric TBI
Source: ClinicalTrials.gov NCT01933217 ↗Enrolled (actual)
26
Serious AEs
2.5%
Results posted
Jun 2020
Primary outcomePrimary: Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS) — 1.10; 1.47; .84; 1.14 units on a scale
◆ Published Evidence
Established
22citations · ~3 / year
Benefits of Methylphenidate for Long-Term Attention Problems After Traumatic Brain Injury in Childhood: A Randomized, Double-Masked, Placebo-Controlled, Dose-Titration, Crossover Trial.
Summary
Traumatic Brain Injury (TBI) - methylphenidate treatment
Linked Publications
-
Benefits of Methylphenidate for Long-Term Attention Problems After Traumatic Brain Injury in Childhood: A Randomized, Double-Masked, Placebo-Controlled, Dose-Titration, Crossover Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS) |
1.10; 1.47; .84; 1.14; 1.37; 1.79 | — |
| PRIMARY Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF) |
60.05; 65.20; 54.30; 58.00; 62.40; 67.75 | — |
| SECONDARY Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI) |
96.05; 91.25 | — |
| SECONDARY Teacher Outcome Measure |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01933217) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.