A Pilot Study to Assess Spinal Cord Stimulation To Inhibit Afferent Feedback During Exercise in Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Change in Exercise Pressor Reflex From Baseline
研究概览
简要总结
To investigate the exercise blood pressure response during a lower-extremity dynamic exercise in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord stimulation reduces blood pressure during exercise in postmenopausal women and men with hypertension.
详细描述
This is a single center study conducted at the University of Minnesota, enrolling up to forty subjects (30 men and 30 post-menopausal women). Subjects will be a assigned to one of the two study arms, (Dynamic Exercise or Spinal Cord Stimulation) and then crossover to the other arm after the initial assignment is complete. However is the screening MRI determines the subject is not a candidate for spinal cord stimulation, then they will be assigned to the Dynamic Exercise arm only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and post-menopausal women between the ages of 40-90 years old
- •Hypertension (defined as BP ≥ 140/90), diagnosed by a physician
- •Ability of the patient to provide consent
排除标准
- •History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire.
- •History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision)
- •Currently taking specific anti-hypertensive medications that may affect the exercise pressor response or influence the effect of spinal cord stimulation.
- •Please contact study staff for information regarding your eligibility.
- •History of spinal fusion or laminectomy at L3 or above
- •Current prescription opioid usage
- •Contraindication to MRI
- •At physician discretion which will be documented on the case report form.
结局指标
主要结局
Change in Exercise Pressor Reflex From Baseline
时间窗: 2 years
Change in blood pressure during exercise.
次要结局
未报告次要终点