The aim of this study is to investigate the potential of transcutaneous neuromodulation (TNM) to treat slow colonic transit and constipation, termed the Neurogenic bowel dysfunction (NBD), in people with SCI. In this project, the study team will investigate the impact of an active treatment intervention vs. a sham control intervention on NBD symptoms in patients with SCI. The study hypotheses: * The proposed TNM treatment at a leg point will reduce NBD symptoms between baseline and post-therapy, when compared to the sham-TNM treatment. * The therapeutic effect of TNM to improve the NBD symptoms is associated with improvement of the autonomic function in SCI patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
This will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have. In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial.
This will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have. In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial.
After 4 weeks of blinded treatment sham participants will be given the option to continue open-label TNM treatment at a leg point acupoint. Participants that agree to this will be re-trained and allowed to keep the AccelBand for another 2 weeks. During this stage, participants will be asked to complete daily home-based TNM treatment and complete the daily online symptom questionnaires. Participants will complete a visit following this additional treatment.
University of Michigan
Ann Arbor, Michigan, United States
The Neurogenic Bowel Dysfunction (NBD) score
The scoring the degree of NBD symptoms and bowel routines, including frequency of bowel movements (0, 1 or 6 points), headache, perspiration or discomfort before or during defecation (0 or 2 points), medications for constipation (0, to 4 points), time used for each defecation (0, 3 or 7 points), frequency of digital stimulation or evacuation (0, 6 points), frequency of fecal incontinence (0, 6, 7 or13 points), medication for fecal incontinence (0, or 4 points), flatus incontinence (0 pr 2 points) and perianal skin problems (0 or 3 points). The score range is between 0-47 with a higher score meaning greater bowel dysfunction.
Time frame: Baseline (phase-in) to 4-week visit
Prolonged colonic transit measurement to assess NBD severity
This will be assessed using abdominal X-ray (which will allow researchers to evaluate participants bowel activity over time) as the retention of radiopaque markers after ingestion of one gelatin capsule with 24 radiopaque markers, 72 hours before visit.
Time frame: Baseline and approximately the 4-week post treatment visit
Daily Medication use for neurogenic bowel use
Use of medications: name, dose, frequency of medications and duration.
Time frame: Baseline (phase-in) to 4-week visit
Bowel routine techniques
Duration and types of bowel routine techniques will be tracked by the bowel diary application (app).
Time frame: Baseline (phase-in) to 4-week visit
Number of bowel movements per week
This will be tracked by the bowel diary application (app).
Time frame: Baseline (phase-in) to 4-week visit
Bristol stool form scale (BSFS)
Bristol stool form scale scores the stool appearance for each bowel movement as proxy for colonic transit based on stool consistency (hard (1) to liquid (7) and shape tracked by the bowel diary app.
Time frame: Baseline (phase-in) to 4-week visit
SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD)
This survey has 26 questions with scoring of 15 factors related to feelings of distress associated with bowel management difficulties in the past week scored from 1 ("none at all" or "never") to 5 ("very much" or "always") to create the overall range of (26-130) with a higher score indicting lower quality of life.
Time frame: Baseline (phase-in) to 4-week visit
Gastrointestinal Symptom Rating Scale (GSRS)
This scare uses a 7-point Likert type scale from 1 (no discomfort) to 7(very severe discomfort) to rate 15 symptom items including both upper and lower abdominal symptoms. There is a range of scores from 15-105 with a higher score indicating more discomfort.
Time frame: Baseline (phase-in) to 4-week visit
Number of Adverse events (serious and non-serious)
The severity, relatedness, and expectedness will be noted (per protocol) by the following: * Mild, Moderate, Severe * Relationship to study products: Associated or Not associated * Expected or unexpected
Time frame: Baseline to post treatment visit (approximately 4 weeks)
Fecal loading in the colon
This will be scored from 1 to 5 from the abdominal X-rays, where: 1 - none, 2 - mild, 3 - moderate, 4 - severe, and 5 - severe with colon dilatation.
Time frame: Baseline and approximately the 4-week post treatment visit
Anorectal Manometry Test (AMT) - sensory thresholds
This will be assessed at the clinic with anorectal manometry (ARM) during rectal balloon distention, sensory thresholds for the first sensation, urge to defecation, and maximal tolerance.
Time frame: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - rectal inhibitory reflex
This will be assessed at the clinic with anorectal manometry (ARM).
Time frame: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain
This will be assessed at the clinic with Anorectal manometry (ARM).
Time frame: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction
This will be assessed at the clinic with Anorectal manometry (ARM).
Time frame: approximately 4-week post treatment visit
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