Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
研究概览
简要总结
Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.
详细描述
Based on available evidence, TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with fewer risk. We are asking several key questions: (1) what are the effects of TSCS on seated BP and BP changes during an orthostatic challenge, (2) is the application of TSCS during AIR tolerable based on pain reporting, (3) is there evidence of superficial burns to the skin near the site of cathode or anode placement, and (4) are the symptoms of orthostatic intolerance reduced with TSCS? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: a standard, easy to follow algorithm that will maximize individual benefits of spinal neuromodulation, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured SCI population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by autonomic nervous system dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participant awareness during TSCS appears to be unavoidable. The FDA recognizes that some trials of non-pharmacological interventions cannot be fully shammed or blinded, yet with careful blinding of data assessors, it is possible to obtain reliable results that meet FDA approval criteria.
入排标准
- 年龄范围
- 14 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly injured patients with traumatic SCI
- •Admitted to Acute Inpatient Rehabilitation at Mount Sinai
- •Within one year of SCI
- •Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
- •Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
- •Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg
- •At least 14 years old
排除标准
- •Implanted brain/spine/nerve stimulators
- •Cochlear implants
- •Cardiac pacemaker/defibrillator, or intracardiac lines
- •Open skin lesions on or near the electrode placement sites (neck, upper back)
- •Significant coronary artery or cardiac conduction disease
- •Recent history of myocardial infarction
- •Insufficient mental capacity to understand and independently provide consent
- •Pregnancy
- •Deemed unsuitable by study physician
结局指标
主要结局
The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
时间窗: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.
The safety (#1) of TSCS to improve autonomic control following acute SCI.
时间窗: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).
The safety (#2) of TSCS to improve autonomic control following acute SCI.
时间窗: Acute Inpatient Rehabilitation following SCI (up to 4 months)
Document any skin changes (burns) following use of TSCS in count of occurrences.
次要结局
- The efficacy (#2) of TSCS to improve autonomic control following acute SCI.(Acute Inpatient Rehabilitation following SCI (up to 4 months))
研究者
Jill M. Wecht, Ed.D.
Research Health Scientist
James J. Peters Veterans Affairs Medical Center