Stroke
Conditions
Keywords
A stroke that occurred three months to four years ago
Brief summary
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
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.
Interventions
An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
DRUGPlacebo
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
Sponsors
Relox Medical, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects of either sex above 18 years of age 2. Documented history of stroke 3 months to four years ago 3. Subjects may have had two or more strokes 4. Must have residual muscle weakness with a 25% or greater difference in strength between the right and left sides of the body 5. Must be assessed as a 2 or 3 on the Modified Rankin Scale 6. Must have a Barthel score at or below 85
Exclusion criteria
1. Any traumatic brain injury or other brain injury apart from stroke 2. Renal insufficiency or renal failure 3. Any medical or physical condition that would interfere with the measurements to be conducted 4. Any physical therapy in a facility outside their home within three days of screening
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed