Methylphenidate for Attention Problems After Pediatric TBI

NCT01933217 | Completed Phase 4 Results

• 1 other identifier: 1K23HD074683-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic Brain Injury (TBI) - methylphenidate treatment

Conditions

Traumatic Brain Injury; TBI; ADHD

Keywords

TBI; traumatic brain injury; ADHD; methylphenidate; Concerta; attention problems

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Methylphenidate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Methylphenidate DRUG

Also known as: Concerta

Methylphenidate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 30169436 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Brad Kurowski, MD, MS
• Organization: Children's Hospital Medical Center, Cincinnati

brad.kurowski@cchmc.org

513-803-3655

Study Officials

• Brad Kurowski, MS, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: September 2, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-04

Locations

US (1)