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Magnesium Therapy in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02510222
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University

Study Description
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Brief Summary:

This study is considered a pilot exploratory study. Intervention, prospective, double-armed, randomized, placebo-control clinical trial.

The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be studied.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Dietary Supplement: Oral magnesium sulfate Other: Placebo Not Applicable

Detailed Description:

Spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy.

Decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family.

The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy.

Hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral Magnesium sulfate
Magnesium sulphate 4% concentration orally ( 65 mg per day for children one to three years of age; 110 mg per day for children four to eight years of age; 350 mg per day for children older than eight years) for 1 month
 Dietary Supplement: Oral magnesium sulfate
Magnesium sulfate 4% concentration in a dose of 65 mg/day for infants and children aged 1-3 years , 110 mg/day for those 3-8 years and 350 mg/day for those above 9 years .Each 1 ml of the magnesium sulfate used contains 0.325 mEq (milliequivalent) of elemental magnesium which equals to 4 mg elemental magnesium .
Placebo Comparator: Control
Fifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo.
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Improvement in H/M ratio in H-reflex by electrophysiologic assessment [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age below12 years.
  • Presence of spasticity without joint contracture Spasticity is defined as velocity dependent, increased resistance to passive muscle stretch.
  • Acceptance of caregivers to participate in the study and signing the written consent.
  • Constipation will be defined according to Rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (Burgers et al., 2012).

Exclusion Criteria:

  • Severe growth retardation (Below the 10th centile for weight and length charts children with cerebral palsy).
  • Gastrostomy tube feeding.
  • Joint contractures.
  • Congenital malformations.
  • Suspected inborn error of metabolism.
  • Suspected inherited neurologic disease.
  • Care giver's refusal to participate in the study.
  • Occurrence of side effects of oral magnesium sulfate.
  • Patients with cardiac, renal, GIT problem or chronic diarrhea.
Contacts and Locations
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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): NCT02510222


Locations
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Egypt
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, Egypt, 11381
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Sahar MA Hassanein, PhD, MD Pediatric department, Faculty of Medicine , Ain Shams University
More Information
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Responsible Party: Sahar M.A. Hassanein, MD, Professor of Pediatrics , Faculty of Medicine, Ain Shams University
ClinicalTrials.gov Identifier: NCT02510222    
Other Study ID Numbers: Pediatrics MS
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Sahar M.A. Hassanein, MD, Ain Shams University:
child
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents