Improving Bowel Function and Quality of Life After Spinal Cord Injury (NCT03949660) | Clinical Trial Compass
UnknownNot Applicable
Improving Bowel Function and Quality of Life After Spinal Cord Injury
United States36 participantsStarted 2018-09-15
Plain-language summary
Bowel dysfunction is consistently rated as one of the most common complications affecting daily life for individuals with spinal cord injury. The overall objective of this study is to investigate whether the use of specific spinal cord epidural stimulation will affect bowel function. This study will also examine how alterations in bowel function influence quality of life outcomes. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired bowel function.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years of age at the time of enrollment
* At least 2 years post injury
* Non-progressive spinal cord injury
* Stable medical condition
* Unable to voluntarily move all joints of the legs
* Unable to stand independently
* Cardiovascular dysfunction including presence of persistent resting low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in 24 hour period
* Bowel dysfunction as a result of spinal cord injury
Exclusion Criteria:
* Ventilator dependent
* Untreated painful musculoskeletal dysfunction, unhealed fracture or pressure sore
* Untreated psychiatric disorder or ongoing drug abuse
* Colostomy bag
* Any implanted pump (i.e., baclofen pump, pain pump, etc)
* Cardiovascular or bowel dysfunction unrelated to SCI
* Ongoing nicotine use
* Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wireless Motility Capsule
Timeframe: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
2
Ambulatory blood pressure and heart rate monitoring
Timeframe: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
3
Anorectal Manometry (ARM)
Timeframe: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
4
Bowel Diary
Timeframe: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
5
International spinal cord injury bowel function basic data set (Version 2.0)
Timeframe: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
6
Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management.
Timeframe: Change from Baseline after 4 months, 8 months, 14 months, 20 months.