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出境医 / 临床实验 / Improving Bowel Function and Quality of Life After Spinal Cord Injury
Improving Bowel Function and Quality of Life After Spinal Cord Injury
Study Description
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurogenic Bowel | Device: Stimulation for blood pressure without stand Device: Stimulation for blood pressure with stand Device: Stimulation for trunk and core without stand Device: Stimulation for trunk or core with stand | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury |
| Actual Study Start Date : | September 15, 2019 |
| Estimated Primary Completion Date : | January 15, 2022 |
| Estimated Study Completion Date : | September 15, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Epidural stimulation for blood pressure without stand
To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI
|
Device: Stimulation for blood pressure without stand
Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.
|
|
Experimental: Epidural stimulation for blood pressure with stand
To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI
|
Device: Stimulation for blood pressure with stand
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
|
|
Experimental: Epidural stimulation for trunk and core without stand
To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI
|
Device: Stimulation for trunk and core without stand
Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.
|
|
Experimental: Epidural stimulation for trunk and core with stand
To assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI
|
Device: Stimulation for trunk or core with stand
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Contacts
| Contact: April Herrity, PhD | (502) 587-4461 | april.herrity@louisville.edu |
Locations
| United States, Kentucky | |
| Frazier Rehab Institute | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: April Herrity, PhD 502-587-4461 | |
| University of Louisville | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: April Herrity, PhD | |
Sponsors and Collaborators
University of Louisville
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||
| First Posted Date ICMJE | May 14, 2019 | ||||
| Last Update Posted Date | November 4, 2020 | ||||
| Actual Study Start Date ICMJE | September 15, 2019 | ||||
| Estimated Primary Completion Date | January 15, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Bowel Function and Quality of Life After Spinal Cord Injury | ||||
| Official Title ICMJE | Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury | ||||
| Brief 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. | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Neurogenic Bowel | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
36 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 15, 2022 | ||||
| Estimated Primary Completion Date | January 15, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03949660 | ||||
| Other Study ID Numbers ICMJE | 19.0435 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | April Herrity, University of Louisville | ||||
| Study Sponsor ICMJE | University of Louisville | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Louisville | ||||
| Verification Date | November 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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