Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- 19.1194 Will determine change in systolic blood pressure during filling during cystometry
研究概览
简要总结
This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arm 1 Inclusion Criteria:
- •At least 18 years of age;
- •AIS A to D;
- •Neurogenic bladder and bowel dysfunction;
- •Stable medical condition
- •Arm 2 Inclusion Criteria:
- •At least 18 years of age;
- •AIS A to D;
- •Neurogenic bladder and bowel dysfunction;
- •Use of intermittent catheterization for bladder emptying;
- •Prior implantation of a Medtronic scES array
- •Arms 1 and 2
排除标准
- •Prior Botox injections of the bladder and/or bladder augmentation surgery;
- •Colostomy bag,
- •Ventilator dependent;
- •Any implanted pump (i.e. Baclofen pump, pain pump, etc.);
- •Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
研究组 & 干预措施
Measure symptomatic indices of autonomic dysreflexia
The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation.
Cardiovascular spinal cord epidural stimulation
The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation.
干预措施: Spinal Cord Epidural Stimulation (Device)
结局指标
主要结局
19.1194 Will determine change in systolic blood pressure during filling during cystometry
时间窗: 2 hours
We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments
19.1194 Will determine maximum change in systolic blood pressure during Anorectal Manometry assessments
时间窗: 1 hour
We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments
17.1024 BB-IS-2 Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)
时间窗: 6 months
We will record systolic blood pressure every five minutes over a 24 hour period using a 24-hour blood pressure monitorTime Frame: Baseline, 80 sessions (6 months)
次要结局
- 19.1194 Will collect data on presence or absence of sensation during Urodynamics cystometry and Anorectal Manometry assessments(3 hours)
- 19.1194 Will determine if level of injury, completeness of injury or gender have a significant effect on maximum changes in blood pressure(5 years)
- 17.1024 BB-IS-2 Change from baseline in bladder capacity after 80 sessions (6 months)(6 months)
- 17.1024 BB-IS-2 Change from baseline in detrusor pressure after 80 sessions (6 months)(6 months)
- 17.1024 BB-IS-2 Change from baseline in mean resting anal pressure after 80 sessions (6 months)(6 months)
- 17.1024 BB-IS-2 Change from baseline in mean squeeze pressure after 80 sessions (6 months)(6 months)
研究者
Charles Hubscher
Professor
University of Louisville