Stimulation for trunk and core without stand for Neurogenic Bowel

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neurogenic BowelStimulation for trunk and core without stand - Device
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a certain type of spinal cord stimulation can help improve bowel function for people with spinal cord injuries, which often leads to impaired quality of life.

Eligible Conditions
  • Neurogenic Bowel

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 0 Secondary · Reporting Duration: Change from Baseline after 4 months, 8 months, 14 months, 20 months.

Month 20
Ambulatory blood pressure and heart rate monitoring
Anorectal Manometry (ARM)
Bowel Diary
Defecation
Interviews
Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management.
Wireless Motility Capsule

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Epidural stimulation for trunk and core without stand
1 of 4
Epidural stimulation for blood pressure with stand
1 of 4
Epidural stimulation for blood pressure without stand
1 of 4
Epidural stimulation for trunk and core with stand
1 of 4

Experimental Treatment

36 Total Participants · 4 Treatment Groups

Primary Treatment: Stimulation for trunk and core without stand · No Placebo Group · N/A

Epidural stimulation for trunk and core without stand
Device
Experimental Group · 1 Intervention: Stimulation for trunk and core without stand · Intervention Types: Device
Epidural stimulation for blood pressure with stand
Device
Experimental Group · 1 Intervention: Stimulation for blood pressure with stand · Intervention Types: Device
Epidural stimulation for blood pressure without stand
Device
Experimental Group · 1 Intervention: Stimulation for blood pressure without stand · Intervention Types: Device
Epidural stimulation for trunk and core with stand
Device
Experimental Group · 1 Intervention: Stimulation for trunk or core with stand · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline after 4 months, 8 months, 14 months, 20 months.

Who is running the clinical trial?

University of LouisvilleLead Sponsor
314 Previous Clinical Trials
72,904 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The student must be at least 18 years old when they enroll in the program.
means that the spinal cord is injured and the injured person will not get better
The patient has a stable medical condition.
You are unable to stand independently.
, and/or symptomatic hypotension The patient has cardiovascular dysfunction, including low blood pressure that persists even when the patient is at rest, and autonomic dysreflexia and orthostatic hypotension, which cause uncomfortable and potentially dangerous symptoms
The bowels may not work properly after a spinal cord injury
You are unable to voluntarily move all joints of the legs.