跳至主要内容
临床试验/NCT06948175
NCT06948175Enrolling By Invitation不适用

Abdominal Transcutaneous Electrical Stimulation to Alleviate Neurogenic Bowel Dysfunction in People With Chronic Spinal Cord Injury

University of Alberta2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
12
试验地点
2
主要终点
Mean defecation time at 2 weeks

研究概览

简要总结

Many people with spinal cord injury (SCI) have bowel problems resulting in constipation and need a long time to empty the bowel. Some people spend an hour or more to empty their bowel. The investigators want test if using a small device to deliver electrical pulses to the belly (abdomen), would improve bowel function. The investigators hope that electrical stimulation will shorten the time needed to evacuate the bowel (defecation), improve stool consistency, and speed up food passing through the bowel. A pilot study found that electrical stimulation of the belly can speed up defecation if stimulation is making the abdominal muscles contract and squeeze the belly, which is what the investigators expected. However, some results suggested that people may benefit from low stimulation levels without making the muscles contract.

Therefore, the investigators will do small study at the University of Alberta on 12 people who lived with SCI for more than 1 year, to find out the best way to apply the electrical stimulation, and to better understand how it works. The participants will use an electrical stimulator at home, to stimulate the skin with 4 sticky pads attached over the abdomen, without causing the muscles to contract. During a 2-month period, they will use the stimulator for 30 minutes before every bowel routine. The investigators will compare how long it takes to empty the bowel, stool consistency, and how long it takes for food to pass through the bowel, with and without using the electrical stimulator.

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Traumatic or non-traumatic SCI
  • •>1 year post injury
  • •Injury level C2 - S5 (NLI, neurological level of injury)
  • •AIS A, B, C, D (American Spinal Injury Association Impairment Scale)
  • •Feels defecation takes too long and wants to do something about it
  • •Defecation takes > 30 minutes

排除标准

  • •Bladder stimulator
  • •Inflammatory bowel disease
  • •Unable to give consent

研究组 & 干预措施

Abdominal TES

Experimental

Abdominal transcutaneuous electrical stimulation (TES)

干预措施: Abdominal transcutaneous electrical stimulation (TES) (Device)

结局指标

主要结局

Mean defecation time at 2 weeks

时间窗: 2 weeks after enrollment (after 2 weeks of usual bowel routine)

Mean defecation time for all bowel routines from 0 to 2 weeks (2 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.

Mean defecation time at 6 weeks

时间窗: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)

Mean defecation time for all bowel routines from 2 to 6 weeks (4 weeks of optimized bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.

Mean defecation time at 14 weeks

时间窗: 14 weeks after enrollment (after 8 weeks of abdominal TES)

Mean defecation time for all bowel routines from 6 to 14 weeks (8 weeks of abdominal TES). Defecation time = time from initiation of bowel movement to the end of stool evacuation.

Mean defecation time at 18 weeks

时间窗: 18 weeks after enrollment (after 4 weeks of usual bowel routine)

Mean defecation time for all bowel routines from 14 to 18 weeks (4 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation.

次要结局

  • Bristol Stool Form(Every bowel routine)
  • Bowel Transit Time at 2 weeks(2 weeks after enrollment (after 2 weeks of usual bowel routine))
  • Bowel Transit Time at 14 weeks(14 weeks after enrollment (after 8 weeks of abdominal TES))
  • Neurogenic Bowel Dysfunction Score (NBDS) at 6 weeks(6 weeks after enrollment (after 4 weeks of optimized bowel routine))
  • Participant Feedback(18 weeks after enrollment (end of study))
  • Bowel Transit Time at 6 weeks(6 weeks after enrollment (after 4 weeks of optimized bowel routine))
  • Bowel Transit Time at 18 weeks(18 weeks after enrollment (after 4 weeks of usual bowel routine))
  • Neurogenic Bowel Dysfunction Score (NBDS) at 18 weeks(18 weeks after enrollment (after 4 weeks of usual bowel routine))
  • Neurogenic Bowel Dysfunction Score (NBDS) at 2 weeks(2 weeks after enrollment (after 2 weeks of usual bowel routine))
  • Neurogenic Bowel Dysfunction Score (NBDS) at 14 weeks(14 weeks after enrollment (after 8 weeks of abdominal TES))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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