Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population

February 25, 2019 updated by: Loewenstein Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Raanana, Israel, 43100
        • Loewenstein Rehabilitation Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female.
  2. Ages 4-18 years old.
  3. No contraindications for Methylphenidate treatment such as hypersensitivity, cardiac disturbances unbalanced seizures etc'.
  4. Informed consent given by their legal guardian.
  5. Acquired brain injury

Exclusion Criteria:

  1. Refusal to participate by either guardian or child.
  2. No attentional disturbances in a computed screening exam: "TOVA".
  3. Medical contraindications to treatment with Methylphenidate such as short QT syndrome.
  4. Side effects due to treatment with Methylphenidate.
  5. Under medical treatment of medications enhancing dopamine/ noradrenaline release such as Amantadine.
  6. Unable to participate in tasks planned due to severe motor or cognitive disabilities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylphenidate treatment
On three different days each participant will receive Methylphenidate in a dosage of 0.3 milligram/kilo rounded to the nearest full milligram dosage
Drug: Methylphenidate
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 Names:
  • Ritalin
No Intervention: Control
On three different days each participant will be re-evaluated without recieveing Methylphenidate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loewenstein Hospital

Investigators

  • Principal Investigator: Sharon Shaklai, Dr, Loewenstein Hospital Rehabilitation Center
  • Study Director: Sigal Greenbaum, Master, Loewenstein Hospital Rehabiltation Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 30, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • loe130007ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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