Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Официальное название

Pilot Trial of the Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Обзор

The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.

Подробное описание

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.

Вмешательства

• Устройство Vibrant Capsule
  The Vibrant capsule is designed to alleviate chronic constipation by stimulating the colon through gentle vibrations. The Vibrant capsule will be swallowed and tracked through the digestive system of spinal cord injury patients.

Первичные конечные точки

• Safety of Vibrant capsule as indicated by number of participants who had an adverse event [Срок оценки: baseline week 1, baseline week 2, baseline week 3, baseline week 4]
• Safety of Vibrant capsule as indicated by number of participants who had an adverse event [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment]
• Safety as assessed by average weekly Numerical Pain Score [Срок оценки: baseline week 1, baseline week 2, baseline week 3, baseline week 4]
• Safety as assessed by average weekly Numerical Pain Score [Срок оценки: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment]
• Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS) [Срок оценки: baseline, week 3]
• Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS) [Срок оценки: week 1 with treatment, week 4 with treatment]

Вторичные конечные точки (2)

• Feasibility as indicated by the number of participants that adhere to the prescribed use of Vibrant [Срок оценки: from week 1 with treatment to week 4 with treatment]
• Feasibility of using the Vibrant capsule as indicated by a satisfaction survey [Срок оценки: end of study (4 weeks after start of treatment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

США · 1 центр

• TIRR Memorial Hermann — Houston

Публикации

• American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. Am J Gastroenterol. 2005;100 Suppl 1:S1-4. doi: 10.1111/j.1572-0241.2005.50613_1.x. No abstract available. PMID 16008640
• Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25. PMID 32449277
• Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6. PMID 25484196
• Qi Z, Middleton JW, Malcolm A. Bowel Dysfunction in Spinal Cord Injury. Curr Gastroenterol Rep. 2018 Aug 29;20(10):47. doi: 10.1007/s11894-018-0655-4. PMID 30159690

Идентификаторы

NCT: NCT07213986 · HSC-MS-25-0364 · Project# 0019646

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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