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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- Barthel Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Magnesium infusion in patients breathing 100% oxygen
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).
干预措施: Magnesium Chloride (Drug)
Placebo infusion
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Barthel Index
时间窗: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions
次要结局
- 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)
研究者
Bert Spilker
Lead Principal Investigator
Relox Medical, LLC