Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population
1 other identifier
interventional
34
1 country
1
Brief Summary
The purpose of this study is to investigate the influence of Methylphenidate in pediatric acquired brain injury population, regarding ecologic (every day) function. It is hypothesized that the function with treatment will improve when compared to function without treatment in the same patient. Improvement is expected by shortening time of execution in each specific task and by reduction of the amount of assistance needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 26, 2019
September 1, 2018
3.1 years
July 1, 2014
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure time (in minutes and seconds) and the amount of assistance needed (number of times each participant needed assistance) to complete the different tasks.
Measure the effect of Methylphenidate on function (in everyday tasks like dressing) of children with acquired brain injury
After each task is completed time of the specific task will be recorded. Each participant will be tested 6 times 45 minutes during 3 weeks and will be followed for duration of hospital stay an expected average of 1 month
Study Arms (2)
Methylphenidate treatment
EXPERIMENTALOn three different days each participant will receive Methylphenidate in a dosage of 0.3 milligram/kilo rounded to the nearest full milligram dosage
Control
NO INTERVENTIONOn three different days each participant will be re-evaluated without recieveing Methylphenidate.
Interventions
On three different days each participant will receive Methylphenidate in a dosage of 0.3 milligram/kilo rounded to the nearest full milligram dosage
Eligibility Criteria
You may qualify if:
- Male and female.
- Ages 4-18 years old.
- No contraindications for Methylphenidate treatment such as hypersensitivity, cardiac disturbances unbalanced seizures etc'.
- Informed consent given by their legal guardian.
- Acquired brain injury
You may not qualify if:
- Refusal to participate by either guardian or child.
- No attentional disturbances in a computed screening exam: "TOVA".
- Medical contraindications to treatment with Methylphenidate such as short QT syndrome.
- Side effects due to treatment with Methylphenidate.
- Under medical treatment of medications enhancing dopamine/ noradrenaline release such as Amantadine.
- Unable to participate in tasks planned due to severe motor or cognitive disabilities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loewenstein Rehabilitation Hospital Center
Raanana, 43100, Israel
Related Publications (6)
Willmott C, Ponsford J. Efficacy of methylphenidate in the rehabilitation of attention following traumatic brain injury: a randomised, crossover, double blind, placebo controlled inpatient trial. J Neurol Neurosurg Psychiatry. 2009 May;80(5):552-7. doi: 10.1136/jnnp.2008.159632. Epub 2008 Dec 5.
PMID: 19060022BACKGROUNDHornyak JE, Nelson VS, Hurvitz EA. The use of methylphenidate in paediatric traumatic brain injury. Pediatr Rehabil. 1997 Jan-Mar;1(1):15-7. doi: 10.3109/17518429709060937.
PMID: 9689233BACKGROUNDWhyte J, Hart T, Schuster K, Fleming M, Polansky M, Coslett HB. Effects of methylphenidate on attentional function after traumatic brain injury. A randomized, placebo-controlled trial. Am J Phys Med Rehabil. 1997 Nov-Dec;76(6):440-50. doi: 10.1097/00002060-199711000-00002.
PMID: 9431261BACKGROUNDWhyte J, Hart T, Vaccaro M, Grieb-Neff P, Risser A, Polansky M, Coslett HB. Effects of methylphenidate on attention deficits after traumatic brain injury: a multidimensional, randomized, controlled trial. Am J Phys Med Rehabil. 2004 Jun;83(6):401-20. doi: 10.1097/01.phm.0000128789.75375.d3.
PMID: 15166683BACKGROUNDWheaton P, Mathias JL, Vink R. Impact of pharmacological treatments on cognitive and behavioral outcome in the postacute stages of adult traumatic brain injury: a meta-analysis. J Clin Psychopharmacol. 2011 Dec;31(6):745-57. doi: 10.1097/JCP.0b013e318235f4ac.
PMID: 22020351BACKGROUNDMahalick DM, Carmel PW, Greenberg JP, Molofsky W, Brown JA, Heary RF, Marks D, Zampella E, Hodosh R, von der Schmidt E 3rd. Psychopharmacologic treatment of acquired attention disorders in children with brain injury. Pediatr Neurosurg. 1998 Sep;29(3):121-6. doi: 10.1159/000028705.
PMID: 9838263BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Shaklai, Dr
Loewenstein Hospital Rehabilitation Center
- STUDY DIRECTOR
Sigal Greenbaum, Master
Loewenstein Hospital Rehabiltation Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2014
First Posted
August 27, 2014
Study Start
January 1, 2014
Primary Completion
January 30, 2017
Study Completion
March 1, 2017
Last Updated
February 26, 2019
Record last verified: 2018-09