Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Abdominal transcutaneous electrical stimulation (TES)
  Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)

Первичные конечные точки

• Mean defecation time at 2 weeks [Срок оценки: 2 weeks after enrollment (after 2 weeks of usual bowel routine)]
• Mean defecation time at 6 weeks [Срок оценки: 6 weeks after enrollment (after 4 weeks of optimized bowel routine)]
• Mean defecation time at 14 weeks [Срок оценки: 14 weeks after enrollment (after 8 weeks of abdominal TES)]
• Mean defecation time at 18 weeks [Срок оценки: 18 weeks after enrollment (after 4 weeks of usual bowel routine)]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Glenrose Rehabilitation Hospital — Edmonton

Идентификаторы

NCT: NCT06948175 · Pro00150346 · G2025-13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗