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Dopamine Treatment in Children With Cerebral Palsy With Dystonia- A Double Blind Controlled Study

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ClinicalTrials.gov Identifier: NCT01361373
Recruitment Status : Unknown
Verified May 2011 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : May 26, 2011
Last Update Posted : May 27, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE June 6, 2010
First Posted Date  ICMJE May 26, 2011
Last Update Posted Date May 27, 2011
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
QUEST quality of upper extremity skills test score before and after treatment [ Time Frame: 2 years ]
The QUEST is a measure designed to evaluate movement patterns and hand function in children with cerebral palsy. It is administered within a play context. Items are related to quality of movement, not to chronological age. There are 36 items assessing dissociated movements, grasp, protective extension, and weight bearing.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01361373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
box and blocks, 9 hole pegs, pronation/ supination, finger sequencing [ Time Frame: 2 years ]
Difference between test scores before and after treatment. Namely:
  • of box transfered per minute time to complete the 9 hole pegs insertion.
  • pronation/ supination per 20 seconds time to complete 5 finger sequencing rounds
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dopamine Treatment in Children With Cerebral Palsy With Dystonia- A Double Blind Controlled Study
Official Title  ICMJE Not Provided
Brief Summary

Background:

Cerebral palsy (CP) is the main cause of childhood immobility and is defined as a non progressive injury to the developing central nervous system in children younger than 3 years, resulting in neurological and musculoskeletal abnormalities. The main pathophysiological causes are encephalopathy of prematurity (periventricular leukomalacia) hypoxic ischemic encephalopathy. Infections, infracts and migration defects are other less common causes of CP. The brain injury leads to functional motor impairment impacting on daily activities commonly manifests as a movement disorder: pyramidal, leading to spasticity and extra-pyramidal leading to dystonia and chorea. In most cases extensive brain injury causes a mixed movement disorder. Dystonia is defined as involuntary muscle contractions causing twisting and abnormal postures. While the neurological underpinnings of CP remain unknown, a link between low dopamine and increased acetylcholine release has recently been reported in dystonia. Dopamine is considered the first line of treatment in children with dystonia and CP followed by anticholiergic treatment with trihexphenidyl. The recommendation of dopaminergic treatment is based on need to rule out dopamine-responsive-dystonia, a rare genetic disorder, and on single case study reporting improvement in CP. A double blind study support or refute the use of dopamine treatment for dystonic CP was never reported. Working hypothesis and

Aims:

In children with CP due to a clear underlying pathology, dopamine treatment will not improve daily function. Methods: the investigators will perform a double blinded randomized controlled crossover study. 50 children ages 4-18 years with a clear pathophysiological cause for CP will be enrolled. Each child will receive dopamine and placebo treatment for 2 weeks with a 2 week washout interval. Participants will be randomized into 2 groups; one will receive placebo followed by dopamine and the other vice versa. The primary outcome measure, goal-attainment-scale, and secondary outcome functional measures (such as box and blocks, 9 hole pegs, pronation/ supination, finger sequencing) will be assessed at the beginning and end of each treatment as well as parent questionnaires regarding satisfaction and side effects.

Expected results:

No functional improvement with dopamine treatment compared to placebo.

Importance:

supplying sufficient data to support or refute the use of dopamine treatment for dystonic CP.

Probable implications to Medicine:

this may lead to a change in medical treatment guidelines for children with CP.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dystonic Cerebral Palsy
Intervention  ICMJE
  • Drug: L- DOPA
    Sinemet up to 10 mg/kg/ day increasing gradually for 2 weeks
  • Drug: placebo
    placebo for 2 weeks
Study Arms  ICMJE
  • Active Comparator: DOPAMINE
    Sinemet up to 10 mg/kg/day
    Intervention: Drug: L- DOPA
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Publications * Pozin I, Bdolah-Abram T, Ben-Pazi H. Levodopa does not improve function in individuals with dystonic cerebral palsy. J Child Neurol. 2014 Apr;29(4):534-7. doi: 10.1177/0883073812473645. Epub 2013 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clear pathophysiological cause for CP
  • disabling dystonia in upper limbs

Exclusion Criteria:

  • significant contractures
  • psychiatric disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01361373
Other Study ID Numbers  ICMJE -L- Dopa-Cerebral Palsy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hilla Ben Pazi, MD, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shaare Zedek Medical Center
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP