Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke that occurred three months to four years ago.

Detailed Description
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The hypothesis being tested is that these six treatments will improve muscle weakness and lead to an improvement in functioning/activities of daily living as measured by the 100-point Barthel index, three months after their last treatment versus their baseline measure, and that the mean difference between the treatment and placebo groups of patients will be at least three points in this index.

Official Title
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Comparison of Magnesium Chloride Infusions Versus Placebo Administered Concomitantly With 100% Oxygen Given to Patients Who Have Residual Muscle Weakness From a Stroke That Occurred Three Months to Four Years Ago

Conditions
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Stroke

Intervention / Treatment
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* Drug: Magnesium Chloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of either sex above 18 years of age Documented history of stroke 3 months to four years ago Subjects may have had two or more strokes Must have residual muscle weakness with a 25% or greater difference in strength between the right and left sides of the body Must be assessed as a 2 or 3 on the Modified Rankin Scale Must have a Barthel score at or below 85 Exclusion Criteria: Any traumatic brain injury or other brain injury apart from stroke Renal insufficiency or renal failure Any medical or physical condition that would interfere with the measurements to be conducted Any physical therapy in a facility outside their home within three days of screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium infusion in patients breathing 100% oxygen<br>Patients will be given six infusions over three weeks. Each infusion will last between 4 and 10 minutes. They will then return to clinic in 1,2 and 3 months for the same tests (but no infusions will be given). | Drug: Magnesium Chloride<br>* An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen<br>|
| Placebo Comparator: Placebo infusion<br>The patients will receive six placebo infusions after which they will return to clinic at one, two and three months. At the conclusion of the trial those patients who received placebo may elect to receive the active treatment in another (open label) trial that will begin shortly after this one concludes. | Drug: Placebo<br>* A saline placebo will be given as an infusion (six infusions over a three week period) in a double blind manner with the active test agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index |  | Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in muscle strength and function |  | Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions | 
| Change in the Mini-mental status examination |  | Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions | 
| Change in balance, coordination, range of motion |  | Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions | 
| Incidence of adverse events and changes in vital signs |  | Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A stroke that occurred three months to four years ago