Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

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 .
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): On three different days each participant will receive Methylphenidate in a dosage of 0.3 milligram/kilo rounded to the nearest full milligram dosage
Other intervention name(s): Ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acquired pediatric brain injury; Methylphenidate; Traumatic brain injury; Cerebrovascular event; Hypoxic ischemic brain injury; Function (ecologic)