Stimulation for Bowel Emptying

NCT ID: NCT06078176

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-12-31

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.

Conditions

Neurogenic Bowel Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bowel emptying

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 and facilitate bowel emptying. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.

Interventions

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 and facilitate bowel emptying. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Suprasacral spinal cord injury
• Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
• Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
• Neurologically stable
• At least 18 years old
• At least 12 months post neurological injury or disease diagnosis

Exclusion Criteria

• Active sepsis
• Open pressure sores on or around pelvis
• Significant colon trauma or colostomy
• Crohn's disease
• Colonic obstruction or gastrointestinal surgery within last 3 months
• Significant history of autonomic dysreflexia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cesar Colasante-Garrido, MD

Role: PRINCIPAL_INVESTIGATOR

Syracuse VA Medical Center, Syracuse, NY

Dennis Bourbeau, PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland, OH

Locations

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cesar Colasante-Garrido, MD

Role: CONTACT

cesar.colasante@va.gov

(315) 325-4400

Facility Contacts

Khalil N Argent

Role: primary

khalil.argent@va.gov

315-425-4400 ext. 52325

Other Identifiers

B4529-R

Identifier Type: -

Identifier Source: org_study_id