Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 39 for:    "Brain Injury" | "Dopamine"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227056
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Loewenstein Hospital

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.

Condition or disease Intervention/treatment Phase
Acquired Brain Injury Drug: Methylphenidate Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Methylphenidate on Ecologic Function in Paediatric Acquired Brain Injury Population
Study Start Date : January 2014
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


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 Name: Ritalin

No Intervention: Control
On three different days each participant will be re-evaluated without recieveing Methylphenidate.



Primary Outcome Measures :
  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. [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227056


Locations
Layout table for location information
Israel
Loewenstein Rehabilitation Hospital Center
Raanana, Israel, 43100
Sponsors and Collaborators
Loewenstein Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sharon Shaklai, Dr Loewenstein Hospital Rehabilitation Center
Study Director: Sigal Greenbaum, Master Loewenstein Hospital Rehabiltation Center

Publications:
Layout table for additonal information
Responsible Party: Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT02227056     History of Changes
Other Study ID Numbers: loe130007ctil
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: September 2018
Keywords provided by Loewenstein Hospital:
Acquired pediatric brain injury
Methylphenidate
Traumatic brain injury
Cerebrovascular event
Hypoxic ischemic brain injury
Function (ecologic)
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Dopamine Uptake Inhibitors
Dopamine Agents
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents