Pilot Trial of the Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety of Vibrant capsule as indicated by number of participants who had an adverse event
研究概览
简要总结
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
详细描述
The purpose of this study is to see how well the Vibrant capsule works at treating people with spinal cord injury (SCI)-induced upper motor neuron (UMN) neurogenic bowel. This study will test the safety of the Vibrant capsule. This Vibrant capsule has been approved by the Food and Drug Administration (FDA) for chronic idiopathic constipation.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with chronic spinal cord injury (SCI) of more than one year.
- •Stable neurological level and function of SCI for at least six months.
- •Consistent bowel program without changes for at least 3 months.
- •At least one scheduled bowel movement (BM) every three days.
- •Use of digital stimulation, suppositories, enemas, or mini enemas, as part of the scheduled bowel program.
- •Use of oral medications as part of the bowel program.
排除标准
- •Bowel incontinence occurring more than once per week.
- •Non-English-speaking individuals.
- •History of bowel obstruction, ileus, diverticulitis, or bowel surgery for a disease (appendix removal is ok).
- •Persistent autonomic dysreflexia (AD) triggered by bowel movements.
- •Recent changes to spasticity medications within the past month.
- •History of significant gastrointestinal disorders
- •History of Zenker's diverticulum
- •Dysphagia
- •Esophageal stricture
- •Eosinophilic esophagitis or achalasia
- •Pregnancy.
- •Presence of implanted devices that could be affected by proximity to a direct current magnetic field.
研究组 & 干预措施
Vibrant Capsule
干预措施: Vibrant Capsule (Device)
结局指标
主要结局
Safety of Vibrant capsule as indicated by number of participants who had an adverse event
时间窗: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatment
Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)
时间窗: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatment
The total score on the Penn Spasm Frequency Scale (PSFS) ranges from 0 to 7, and a higher score indicates greater spasm frequency and severity.
Safety as assessed by average weekly Numerical Pain Score
时间窗: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatment
The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)
时间窗: week 1 with treatment, week 4 with treatment, week 8 with treatment
The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.
Safety of Vibrant capsule as indicated by number of participants who had an adverse event
时间窗: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment
Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)
时间窗: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment
The total score on the Penn Spasm Frequency Scale (PSFS) ranges from 0 to 7, and a higher score indicates greater spasm frequency and severity.
Safety as assessed by average weekly Numerical Pain Score
时间窗: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment
The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)
时间窗: week 1 with treatment, week 4 with treatment
The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.
Safety of Vibrant capsule as indicated by number of participants who had an adverse event
时间窗: baseline week 1, baseline week 2, baseline week 3, baseline week 4
Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)
时间窗: baseline week 1, baseline week 2, baseline week 3, baseline week 4
The total score on the Penn Spasm Frequency Scale (PSFS) ranges from 0 to 7, and a higher score indicates greater spasm frequency and severity.
Safety as assessed by average weekly Numerical Pain Score
时间窗: baseline week 1, baseline week 2, baseline week 3, baseline week 4
The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)
时间窗: baseline, week 3
The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.
次要结局
- Feasibility of using the Vibrant capsule as indicated by a satisfaction survey(end of study (4 weeks after start of treatment))
- Feasibility as indicated by the number of participants that adhere to the prescribed use of Vibrant(from week 1 with treatment to week 8 with treatment)
- Feasibility of using the Vibrant capsule as indicated by a satisfaction survey(end of study (8 weeks after start of treatment))
- Feasibility as indicated by the number of participants that adhere to the prescribed use of Vibrant(from week 1 with treatment to week 4 with treatment)
- Feasibility of using the Vibrant capsule as indicated by a satisfaction survey(end of study (4 weeks after start of treatment))
研究者
Argyrios Stampas, MD
Professor
The University of Texas Health Science Center, Houston