Working… Menu

Stimulation for Colonic Motility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02641483
Recruitment Status : Enrolling by invitation
First Posted : December 29, 2015
Last Update Posted : January 11, 2021
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Neurogenic Bowel Dysfunction Other: Electrical Rectal Stimulation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Afferent Stimulation to Evoke Recto-colonic Reflex for Colonic Motility
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Colonic Motility
Study participants will act as their own controls, first providing data using their usual digital rectal stimulation intervention for bowel care, then providing data using electrical stimulation for bowel care.
Other: Electrical Rectal Stimulation
Electrical stimulation of the rectum will be applied to activate sensory afferent neurons of the rectum and evoke a recto-colonic reflex to improve colonic motility. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
  • Neurologically stable
  • Skeletally mature
  • Suprasacral spinal cord injury, stroke, or multiple sclerosis
  • At least 6 months post neurological injury or disease diagnosis

Exclusion Criteria:

  • Active sepsis
  • Open pressure sores on or around pelvis
  • Significant colon trauma or colostomy
  • History of autonomic dysreflexia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02641483

Layout table for location information
United States, New York
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Layout table for investigator information
Principal Investigator: Dennis Bourbeau, PhD Louis Stokes VA Medical Center, Cleveland, OH
Layout table for additonal information
Responsible Party: VA Office of Research and Development Identifier: NCT02641483    
Other Study ID Numbers: B1962-W
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Neurogenic Bowel
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases