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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.
Attention deficits in patients with acquired brain injury (ABI) are one of the most common cognitive disorders acquainted. Prevalence of attention deficits after cerebrovascular accident (CVA) varies between 20-58%, and after traumatic brain injury (TBI) may range up to 60% Methylphenidate (MPH) is a central nervous system (CNS) stimulant. In the CNS it increases release and blocks reuptake of dopamine and noradrenalin, resulting in increased synaptic and extracellular concentrations. Methylphenidate (MPH), act at the D1 and α2-adrenergic receptors to facilitate effects on prefrontal cortical modulation of attention and working memory .Methylphenidate has been used effectively and safely for treatment of attention deficit hyperactivity disorder for many decades. The use of Methylphenidate to enhance attention in disorders following TBI has been proposed as "rational pharmacotherapy". It demonstrated improvement in response speed, in adult patients with chronic TBI. In pediatric population suffering Acquired brain injury there are scarce works regarding methylphenidate short or long term efficacy. Since there are scarce reports altogether on Methylphenidate's effect in pediatric Acquired brain injury population and since the studies up to now examined the effectiveness in neuropsychological batteries we find it of interest to examine the effect of Methylphenidate in ecological tasks, thus achieving a better understanding of its possible effect in this subpopulation.
STUDY ASSUMPTIONS:
STUDY POPULATION:
The study is designed to include up to 40 children, aged 4-18 years, suffering attentional disturbances secondary to Acquired Brain Injury (CVA, TBI, Anoxic brain injury, Central Nervous System infections). Participants will be children hospitalized (inpatient or outpatient) for rehabilitation in Loewenstein Rehabilitation Center Hospital, with no contraindications for Methylphenidate treatment after their legal guardian gave informed consent for participation.
STUDY METHODS:
Before inclusion each participant will undergo:
Each participant will be tested on each task twice in two week's period: twice without treatment of Methylphenidate and twice with Methylphenidate treatment.
Some participants will be retested after 7-14 days with no further treatment with Methylphenidate, in order to estimate if influence of the drug on function continues with no further treatment.
Drug will be given at least an hour and not more than 2.5 hours before being tested.
Drug dosage 0.3 milligram/kilo rounded to the nearest full milligram dosage will be given a total of 3 times: once before Test of Variables of Attention (TOVA) exam under Methylphenidate, and two other days while the participant is tested on the different tasks.
Testing will be done in two hours of treatment session on different days.
Each participant will undergo the following tasks, in a consecutive order:
The Occupational therapist scoring the child's abilities and amount assistance needed will be blindfolded to the treatment (given or not).
Performance data in each task will be collected with regard to duration for completion, amount of assistance needed, impulsivity, long term and short term attention etc, and statistically analyzed. Each participant (without Methylphenidate treatment) will serve as control to data collected in the same tasks completed under treatment with Methylphenidate .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate treatment | Experimental | On 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 Intervention | On three different days each participant will be re-evaluated without recieveing Methylphenidate. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | On three different days each participant will receive Methylphenidate in a dosage of 0.3 milligram/kilo rounded to the nearest full milligram dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Shaklai, Dr | Loewenstein Hospital Rehabilitation Center | Principal Investigator |
| Sigal Greenbaum, Master | Loewenstein Hospital Rehabiltation Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loewenstein Rehabilitation Hospital Center | Raanana | 43100 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19060022 | Background | 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. | |
| 9689233 | Background |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D000070642 | Brain Injuries, Traumatic |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Hornyak 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. |
| 9431261 | Background | Whyte 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. |
| 15166683 | Background | Whyte 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. |
| 22020351 | Background | Wheaton 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. |
| 9838263 | Background | Mahalick 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. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |