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.|
|ClinicalTrials.gov Identifier: NCT02641483|
Recruitment Status : Enrolling by invitation
First Posted : December 29, 2015
Last Update Posted : February 20, 2019
|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)|
|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, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
- 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.
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
|United States, Ohio|
|Louis Stokes VA Medical Center, Cleveland, OH|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Dennis Bourbeau, PhD||Louis Stokes VA Medical Center, Cleveland, OH|