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Project

The Wireless Motility Capsule for Neurogenic Bowel in Spinal Cord Injury

Funder: Craig H Neilsen Foundation

Funding period
USD 300 K
Funding amount
Abstract
People with spinal cord injury (SCI) are known to have neurogenic bowels, characterized by constipation and bowel incontinence which significantly affect quality of life. This may be accompanied by considerable abdominal discomfort, bloating, distention, rectal pain. Existing gastrointestinal (GI) tests require substantial burden to the patient since these are difficult to perform. Additionally, these tests do not provide a comprehensive evaluation of GI function and transit. Available research shows prolonged total gastrointestinal transit times and segmental colonic transit times in SCI. Results of gastric emptying time in SCI are inconsistent. The relationship between upper and lower GI symptoms and dysfunction is unclear but is very important in defining the pathophysiology of neurogenic GI dysfunction in SCI. To advance our knowledge and examine this relationship, we will use the Wireless Motility Capsule (WMC), an ingestible capsule that uses sensory technology that allows determination of segmental GI transit times in a single procedure and characterization of patterns of dysmotility in the upper and lower GI tract and the Anal Rectal Manometry/Balloon Expulsion Test (ARM/BET) to evaluate anorectal function. Objective: The primary objective is to determine whether abnormalities in upper GI motility and transit are associated with colonic dysmotility and transit as well as anorectal dysfunction. Second, we wish to determine the relationship of these results to level and completeness of injury, time since injury, age and presence of other comorbidities Two aims guide this study: Specific Aims: Aim 1: To examine and compare findings between those with prolonged versus those with normal gastric emptying times in terms of their colon transit times and anorectal function. Aim 2: To compare persons with SCI who do and do not have upper GI symptoms with respect to regional transit times, and anorectal function. Study Design: Participants will be recruited from University of Michigan Clinical System and the Model SCI Care System Registries and other SCI databases. Participants will complete various demographic, gastrointestinal and bowel surveys. Neurologic status will be evaluated with the International Standards for Neurological Classification of SCI (ISNCSCI) Exam to determine completeness and level of injury. The subjects will undergo the ARM/BET. They will ingest the Wireless Motility Capsule and a recorder will collect information for 7 days. Data from all the tests will undergo statistical analysis with the use of samples t-test to compare colonic transfer times between those with and without upper GI symptoms. To control for potential confounders, this analysis will be reconducted using Analysis of Covariance (ANCOVA), controlling for key factors including: completeness and level of injury, demographic factors, dietary intake and rectal bowel medications. Impact: This study will advance comprehension of direct or indirect effects of SCI (CHN: SCIRTS chn:wdg)
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System

Categories
  • FOR (ANZSRC)

    1103 Clinical Sciences

  • RCDC

    Injury (total) Accidents/Adverse Effects

  • RCDC

    Injury - Trauma - (Head and Spine)

  • RCDC

    Digestive Diseases

  • RCDC

    Neurosciences

  • RCDC

    Spinal Cord Injury

  • RCDC

    Clinical Research

  • RCDC

    Neurodegenerative

  • HRCS HC

    Neurological

  • HRCS HC

    Oral and Gastrointestinal

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science