Clinical Trial: Afferent Stimulation to Evoke Recto-colonic Reflex for Colonic Motility

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Afferent Stimulation to Evoke Recto-colonic Reflex for Colonic Motility

Brief Summary: The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.

Detailed Summary:
Sponsor: VA Office of Research and Development

Current Primary Outcome: Compare changes in colonic pressure (cmH2O) over baseline in response to electrical rectal stimulation versus mechanical rectal distension (control) [ Time Frame: 1 month ]

Two interventions will be tested, including the clinical standard of digital rectal stimulation and a novel approach using electrical stimulation of rectal sensory afferents, to determine the effect on colonic pressure. Increased colonic pressure will indicate successful modulation of neural pathways to increase bowel activity and thereby facilitate defecation in individuals with neurogenic bowel dysfunction.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: VA Office of Research and Development

Dates:
Date Received: December 22, 2015
Date Started: January 2018
Date Completion: December 2019
Last Updated: May 5, 2017
Last Verified: May 2017