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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium infusion in patients breathing 100% oxygen | Experimental | 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). |
|
| Placebo infusion | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Chloride | Drug | An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bert Spilker, PhD, MD | President, Bert Spilker & Associates, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Born Preventive Healthcare Clinic, PC | Grand Rapids | Michigan | 49512 | United States | ||
| Schachter Center for Complementary Medicine |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015636 | Magnesium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | 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 |
|
| 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 |
| Suffern |
| New York |
| 10901 |
| United States |
| Comprehensive Heart Care Inc. | Toledo | Ohio | 43606 | United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017616 |
| Magnesium Compounds |