The Effects of Transcutaneous Abdominal Stimulation on Bowel Function in Persons With Spinal Cord Injury and in Able-bodied Persons With Chronic Constipation.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total defecation time (duration)
研究概览
简要总结
This is a prospective, single-center, feasibility study to determine the sensations elicited by non-invasive abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. Electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit.
详细描述
This is a prospective, single-center, treatment feasibility study to determine the efficacy of electrical stimulation for bowel functions. The study will determine sensations elicited by non-invasive, transcutaneous abdominal electrical stimulation and its effects on bowel function in spinal cord injured individuals and in able-bodied persons with chronic constipation. The electrical stimulation will be delivered through commercially available equipment to each subject during a single site visit. Visits are anticipated to be no more than 5 hours.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For spinal cord injury subject group:
- •Traumatic or non-traumatic spinal cord injury;
- •Constipation;
- •Motor-complete or motor-incomplete spinal cord injury;
- •Quadriplegia or paraplegia;
- •Post-injury time ≥ 1 year;
- •Neurogenic Bowel Dysfunction Score ≥
- •For able-bodied subject group:
- •Diagnosis of intestinal constipation according to the Rome IV criteria;
- •Chronic constipation as defined by < 3 bowel movements per week for > 3 months.
- •For both subject groups:
- •Can read, understand and willingly sign an Institutional Review Board approved informed consent document that describes the study's risks and benefits.
排除标准
- •Presence of any organic cause for intestinal constipation;
- •Have chronic fecal incontinence;
- •Have skin infection/lesion in the area of electrode application or systemic skin disease;
- •Have an implanted electronic device (such as heart pacemaker, insulin or baclofen pump, etc);
- •Have symptomatic cardiac disease;
- •Have uncontrolled diabetes;
- •Presence of abdominal hernia;
- •Have a stoma, rectal tear, or untreated hemorrhoids;
- •Have a significant psychiatric disorder;
- •For female subjects, being pregnant, actively planning a pregnancy or breast-feeding a child;
- •Be participating in another clinical study that would confound data analysis;
- •Have a cognitive impairment or exhibits any characteristic that would limit the study candidate's ability to complete study assessments.
研究组 & 干预措施
Spinal cord injured persons
Persons living with spinal cord injury presenting with constipation due to neurogenic bowel dysfunction.
干预措施: Non-invasive, surface electrical stimulation device, DS5 Digitimer (Device)
Persons without neurogenic bowel dysfunction
Abled-bodied persons with chronic constipation.
干预措施: Non-invasive, surface electrical stimulation device, DS5 Digitimer (Device)
结局指标
主要结局
Total defecation time (duration)
时间窗: 7 days
The time (duration) to complete total defecation following the stimulation.
Duration of the occurrence of first stool
时间窗: 7 days
The time between the onset of transcutaneous abdominal electrical stimulation and the first stool will be measured.
次要结局
未报告次要终点
研究者
Amol Soin, M.D., MBA
Medical Director
Ohio Pain Clinic