Improving Bladder Function in SCI by Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Urine flow and volume
研究概览
简要总结
This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.
详细描述
This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury. Neuromodulation will be in the form of transcutaneous electrical stimulation and/or magnetic 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 18-45 years;
- •At least 1 year post-injury;
- •Non-progressive SCI at C2-T8 (non-conus injury);
- •Motor Complete ASIA (A or B);
- •Neurogenic bladder requiring clean intermittent straight catheterization;
- •Able to attend twice weekly testing sessions for 6 months.
- •Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping.
排除标准
- •History of autonomic dysreflexia;
- •Ventilator dependency;
- •Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection;
- •Clinically significant depression or ongoing drug abuse;
- •Received botox injection, or bladder surgery (suprapubic access, Brindley procedure, etc.);
- •Prostatic hypertrophy or bladder outlet disorder;
- •7. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.
研究组 & 干预措施
Stimulation of Non-Naive
Evaluate neuromodulation in 6 subjects with prior motor training.
干预措施: Electromagnetic Neuromodulation (Device)
Stimulation of Naive
Evaluate neuromodulation in 6 naive subjects.
干预措施: Electromagnetic Neuromodulation (Device)
Stimulation
Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.
干预措施: Electromagnetic Neuromodulation (Device)
结局指标
主要结局
Urine flow and volume
时间窗: Months 1-48
次要结局
未报告次要终点
研究者
Daniel Lu, MD, PhD
Associate Professor
University of California, Los Angeles