Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic spinal cord injury
- •at least 12 months post injury
- •injury level of C1-T6
- •AIS A, B or C
- •non-ambulatory
- •non-ventilator
排除标准
- •Active psychiatric disorder
- •Stroke or cerebrovascular disease
- •Alzheimer's Disease or dementia
- •Unmanaged cardiac arrhythmias
- •Concurrent systemic, hepatic, or renal disease
- •Suspected or diagnosed malignancy
- •Neurological disease other than SCI
- •Self-reported history of three or more symptomatic episodes of AD per day
研究组 & 干预措施
Study 2
Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort.
干预措施: Midodrine Hydrochloride (Drug)
Study 1
Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension.
干预措施: Midodrine Hydrochloride (Drug)
结局指标
主要结局
Systolic blood pressure
时间窗: 3 years
determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo
次要结局
- Symptoms of autonomic dysreflexia and orthostatic hypotension(3 years)
- Cerebral blood flow velocity(3 years)
研究者
Jill M. Wecht, Ed.D.
Research Scientist
James J. Peters Veterans Affairs Medical Center