Neurogenic BowelNCT03949660
Improving Bowel Function and Quality of Life After Spinal Cord Injury
A study testing Stimulation for blood pressure without stand, Stimulation for blood pressure with stand and Stimulation for trunk and core without stand in people with Neurogenic Bowel, run by University of Louisville at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurogenic Bowel
- What is being tested?
- Stimulation for blood pressure without stand, Stimulation for blood pressure with stand and Stimulation for trunk and core without stand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2018to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Frazier Rehab Institute
Louisville, Kentucky, 40202
Susan Harkema, PhD, 502-581-8747
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Susan Harkema, PhD
About this study
Official title: Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
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.
Read the detailed description
Participants in this study must be enrolled in the TS - EPI study (IRB# 16.0179) which provides the spinal cord epidural implant and training interventions. You will receive two sets of interventions, each one lasting 80 sessions for a total of 160 sessions. Assessments for bowel function and quality of life will be performed as part of this study and are conducted at baseline/pre-training, post-Intervention 1, post-Intervention 2, and at the 6-month and 12-month follow-ups. Your participation in this study will last up to 24 months.
- Conditions
- Neurogenic Bowel
- Being tested
- Stimulation for blood pressure without stand, Stimulation for blood pressure with stand, Stimulation for trunk and core without stand, Stimulation for trunk or core with stand
- Keywords
- bowel, spinal cord injury, epidural stimulation
- Medical subject headings
- Neurogenic Bowel, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation for blood pressure without standDevice
Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.
Stimulation for blood pressure with standDevice
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
Stimulation for trunk and core without standDevice
Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.
Stimulation for trunk or core with standDevice
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
| Study group | Role | What they receive |
|---|---|---|
| Epidural stimulation for blood pressure without stand | Experimental | To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI Receives: Device: Stimulation for blood pressure without stand |
| Epidural stimulation for blood pressure with stand | Experimental | To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI Receives: Device: Stimulation for blood pressure with stand |
| Epidural stimulation for trunk and core without stand | Experimental | To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI Receives: Device: Stimulation for trunk and core without stand |
| Epidural stimulation for trunk and core with stand | Experimental | To assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI Receives: Device: Stimulation for trunk or core with stand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wireless Motility Capsule
Use of the FDA approved SmartPill and device to record information about motility.
Measured: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Ambulatory blood pressure and heart rate monitoring
Blood pressure will be recorded over a 24-hour period of time outside the lab using a flexible finger cuff on your non-dominant hand.
Measured: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Anorectal Manometry (ARM)
While lying on your side, while a small, flexible tube, about the size of a thermometer, with a balloon at the end will be inserted into the rectum.
The catheter is connected to equipment that measures pressure. A small balloon attached to the catheter may be inflated in the rectum to assess muscle responses.
You will be asked to relax, squeeze, and push at various times. The anal sphincter muscle pressures are measured during each of these muscle contraction/relaxation actions.
Surface patch EMG electrodes will be placed near the buttocks to evaluate muscle activity of the anal sphincter.
Measured: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Bowel Diary
Keep a log of various aspects of your bowel program, including how often and how long it takes you to complete your program.
Measured: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
International spinal cord injury bowel function basic data set (Version 2.0)
Complete a short questionnaire about your bowel management. 16 items: date of data collection, gastrointestinal and anal sphincter dysfunction unrelated to SCI, surgical procedures on the gastrointestinal tract, defecation method and bowel-care procedures, average time required for defecation, frequency of defecation, uneasiness, headache or perspiration during defecation, digital stimulation or evacuation of the anorectum, frequency of fecal incontinence, flatus incontinence, need to wear pad or plug, oral laxatives and prokinetics, anti-diarrheal agents, perianal problems, abdominal pain and discomfort and the neurogenic bowel dysfunction score are computed by adding the points given in parenthesis after each relevant variable in the data-set. Total score range is from (0-45). Total neurogenic bowel score (optional): 0-6 Very minor, 7-9 Minor, 10-13 Moderate, 14 or more, Severe neurogenic bowel dysfunction.
Measured: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management.
Complete a series of short questionnaires about your quality of life. SCI-QOL measurements scores range from (0-100). It includes 19 calibrated items banks and 3 fixed length scales spanning the broad domains of physical-medical health, emotional health, social participation and physical functioning.
Measured: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Interviews
Interviews about your perspective on changes in bowel management and recovery throughout the study, conducted by a qualitative researcher.
Measured: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start15 Sep 2018
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BowelStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Hubscher, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949660
- Sponsor's protocol ID
- 19.0435
- Status last verified
- Oct 2023
- First submitted
- 7 May 2019
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03949660
- Acronym / sponsor ID
- 19.0435
- Conditions
- Neurogenic Bowel
- Keywords
- bowel, spinal cord injury, epidural stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants in this study must be enrolled in the TS - EPI study (IRB# 16.0179) which provides the spinal cord epidural implant and training interventions. You will receive two sets of interventions, each one lasting 80 sessions for a total of 160 sessions. Assessments for bowel function and quality of life will be performed as part of this study and are conducted at baseline/pre-training, post-Intervention 1, post-Intervention 2, and at the 6-month and 12-month follow-ups. Your participation in this study will last up to 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epidural stimulation for blood pressure without stand | Experimental | Device: Stimulation for blood pressure without standTo assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI |
| Epidural stimulation for blood pressure with stand | Experimental | Device: Stimulation for blood pressure with standTo assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI |
| Epidural stimulation for trunk and core without stand | Experimental | Device: Stimulation for trunk and core without standTo assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI |
| Epidural stimulation for trunk and core with stand | Experimental | Device: Stimulation for trunk or core with standTo assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation for blood pressure without standConsists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day. | Device | Epidural stimulation for blood pressure without stand |
| Stimulation for blood pressure with standConsists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training. | Device | Epidural stimulation for blood pressure with stand |
| Stimulation for trunk and core without standConsists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day. | Device | Epidural stimulation for trunk and core without stand |
| Stimulation for trunk or core with standConsists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training. | Device | Epidural stimulation for trunk and core with stand |
Primary outcome
Wireless Motility Capsule
Time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Use of the FDA approved SmartPill and device to record information about motility.
Ambulatory blood pressure and heart rate monitoring
Time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Blood pressure will be recorded over a 24-hour period of time outside the lab using a flexible finger cuff on your non-dominant hand.
Anorectal Manometry (ARM)
Time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
While lying on your side, while a small, flexible tube, about the size of a thermometer, with a balloon at the end will be inserted into the rectum. The catheter is connected to equipment that measures pressure. A small balloon attached to the catheter may be inflated in the rectum to assess muscle responses. You will be asked to relax, squeeze, and push at various times. The anal sphincter muscle pressures are measured during each of these muscle contraction/relaxation actions. Surface patch EMG electrodes will be placed near the buttocks to evaluate muscle activity of the anal sphincter.
Bowel Diary
Time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Keep a log of various aspects of your bowel program, including how often and how long it takes you to complete your program.
International spinal cord injury bowel function basic data set (Version 2.0)
Time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Complete a short questionnaire about your bowel management. 16 items: date of data collection, gastrointestinal and anal sphincter dysfunction unrelated to SCI, surgical procedures on the gastrointestinal tract, defecation method and bowel-care procedures, average time required for defecation, frequency of defecation, uneasiness, headache or perspiration during defecation, digital stimulation or evacuation of the anorectum, frequency of fecal incontinence, flatus incontinence, need to wear pad or plug, oral laxatives and prokinetics, anti-diarrheal agents, perianal problems, abdominal pain and discomfort and the neurogenic bowel dysfunction score are computed by adding the points given in parenthesis after each relevant variable in the data-set. Total score range is from (0-45). Total neurogenic bowel score (optional): 0-6 Very minor, 7-9 Minor, 10-13 Moderate, 14 or more, Severe neurogenic bowel dysfunction.
Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management.
Time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Complete a series of short questionnaires about your quality of life. SCI-QOL measurements scores range from (0-100). It includes 19 calibrated items banks and 3 fixed length scales spanning the broad domains of physical-medical health, emotional health, social participation and physical functioning.
Interviews
Time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Interviews about your perspective on changes in bowel management and recovery throughout the study, conducted by a qualitative researcher.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Bowel
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Not yet recruitingObservational study
Biophysical Assessments of Acupuncture Points in Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD)
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Recruiting
Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury
Spinal Cord Injury, Neurogenic Bowel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation for blood pressure without stand, Stimulation for blood pressure with stand and Stimulation for trunk and core without stand in people with Neurogenic Bowel, run by University of Louisville at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Harkema, PhD (502-581-8747, susan.harkema@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wireless Motility Capsule (time frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.