Stimulation for Colonic Motility

NCT ID: NCT02641483

Last Updated: 2023-09-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-12-31

Brief Summary

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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 Description

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Conditions

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Neurogenic Bowel Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electrical Rectal Stimulation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Bourbeau, PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

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Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States

Site Status

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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B1962-W

Identifier Type: -

Identifier Source: org_study_id

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