Traumatic Brain InjuryPhase 4NCT01933217
Methylphenidate for Attention Problems After Pediatric TBI
A Phase 4 study testing Methylphenidate in people with Traumatic Brain Injury and TBI, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Traumatic Brain Injury (TBI) - methylphenidate treatment Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Traumatic Brain Injury, TBI, ADHD
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)
Traumatic Brain Injury (TBI) - methylphenidate treatment
Read the 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).
- Conditions
- Traumatic Brain Injury, TBI, ADHD
- Being tested
- Methylphenidate, Placebo
- Keywords
- TBI, traumatic brain injury, ADHD, methylphenidate, Concerta, attention problems
- Medical subject headings
- Brain Injuries, Traumatic, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Concerta
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Reported at End of Methylphenidate Arm (Week 4 or 8)
Teacher Outcome Measure
Used to assess child behavior.
Measured: January 1, 2014 - July 20, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brad Kurowski, MS, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933217
- Sponsor's protocol ID
- 1K23HD074683-01A1
- Status last verified
- Apr 2020
- First submitted
- 15 Jul 2013
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30169436
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT01933217
- Acronym / sponsor ID
- 1K23HD074683-01A1
- Conditions
- Traumatic Brain Injury, TBI, ADHD
- Keywords
- TBI, traumatic brain injury, ADHD, methylphenidate, Concerta, attention problems
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: MethylphenidateThe 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: Concerta | Drug | Methylphenidate |
| Placebo | Drug | Placebo |
Primary outcome
Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)
Time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)
Teacher Outcome Measure
Time frame: January 1, 2014 - July 20, 2017
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30169436Kurowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Kurowski, MS, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Traumatic Brain Injury and TBI, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS) (time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01933217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020; AzTrials last refreshed its copy on 27 Oct 2026.