Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 8:38 AM
Study NCT ID:
NCT02227056
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2014-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population
Sponsor:
Loewenstein Hospital
Organization:
Study Overview
Official Title:
Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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:
1. Methylphenidate has a proved safety profile in pediatric population suffering from primary attention deficit hyperactivity disorder or secondary attention deficit hyperactivity disorder .
2. Methylphenidate has positive influence on attentional disorders in pediatric population suffering from Acquired brain injury in subacute and chronic phases.
3. Methylphenidate can enhance function of children with attentional disturbances secondary to Acquired brain injury in different everyday tasks.
4. Methylphenidate can improve learning in pediatric population suffering from secondary attention deficit hyperactivity disorder after Acquired brain injury, during subacute rehabilitation period.
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:
1. Before inclusion each participant will undergo:
1. ECG
2. A screened computed exam to prove attentional disturbances with the Test of Variables of Attention (TOVA) test.
2. Each participant will be tested on each task twice in two week's period: twice without treatment of Methylphenidate and twice with Methylphenidate treatment.
3. 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.
4. Drug will be given at least an hour and not more than 2.5 hours before being tested.
5. 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.
6. Testing will be done in two hours of treatment session on different days.
7. Each participant will undergo the following tasks, in a consecutive order:
1. Dressing -T-shirt. Burden of care graded by scales of The Functional Independence Measure (FIM) or the Functional Independence Measure for Children (WeeFIM) according to age of participant.
2. Puzzle construction. Two different puzzles to avoid a possibility of learning. Both the same level according to Sheridan's developmental norms.
3. Mathematical age appropriate working sheet.
4. Interactive social game such as memory game. On this task each participant will be scored according to number of reminders given for his round or inhibition and his emotional reaction to winning /loosing the game on a scale of 1-5, 1 being appropriate reaction, 5 being highest frustration.
8. 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 .
STUDY ASSUMPTIONS:
1. Methylphenidate has a proved safety profile in pediatric population suffering from primary attention deficit hyperactivity disorder or secondary attention deficit hyperactivity disorder .
2. Methylphenidate has positive influence on attentional disorders in pediatric population suffering from Acquired brain injury in subacute and chronic phases.
3. Methylphenidate can enhance function of children with attentional disturbances secondary to Acquired brain injury in different everyday tasks.
4. Methylphenidate can improve learning in pediatric population suffering from secondary attention deficit hyperactivity disorder after Acquired brain injury, during subacute rehabilitation period.
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:
1. Before inclusion each participant will undergo:
1. ECG
2. A screened computed exam to prove attentional disturbances with the Test of Variables of Attention (TOVA) test.
2. Each participant will be tested on each task twice in two week's period: twice without treatment of Methylphenidate and twice with Methylphenidate treatment.
3. 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.
4. Drug will be given at least an hour and not more than 2.5 hours before being tested.
5. 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.
6. Testing will be done in two hours of treatment session on different days.
7. Each participant will undergo the following tasks, in a consecutive order:
1. Dressing -T-shirt. Burden of care graded by scales of The Functional Independence Measure (FIM) or the Functional Independence Measure for Children (WeeFIM) according to age of participant.
2. Puzzle construction. Two different puzzles to avoid a possibility of learning. Both the same level according to Sheridan's developmental norms.
3. Mathematical age appropriate working sheet.
4. Interactive social game such as memory game. On this task each participant will be scored according to number of reminders given for his round or inhibition and his emotional reaction to winning /loosing the game on a scale of 1-5, 1 being appropriate reaction, 5 being highest frustration.
8. 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 .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: