ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 97 for:    Recruiting, Not yet recruiting, Available Studies | "Colonic Diseases, Functional"
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02641483
Recruitment Status : Not yet recruiting
First Posted : December 29, 2015
Last Update Posted : August 15, 2018
Sponsor:
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

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

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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT02641483


Contacts
Contact: Dennis Bourbeau, PhD (216) 791-3800 ext 4845 Dennis.Bourbeau@va.gov

Locations
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Dennis Bourbeau, PhD    216-791-3800 ext 4845    Dennis.Bourbeau@va.gov   
Principal Investigator: Dennis Bourbeau, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Dennis Bourbeau, PhD Louis Stokes VA Medical Center, Cleveland, OH

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02641483     History of Changes
Other Study ID Numbers: B1962-W
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Intestinal Diseases
Neurogenic Bowel
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases