Spinal Cord Injuries
Conditions
Keywords
Neurogenic bowel dysfunction, Transcutaneous neuromodulation, Questionnaires, AccelBand, Anorectal manometry test
Brief summary
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.
Interventions
DEVICETNM at a sham-point (AccelBand) - randomized arm
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.
DEVICETNM at a leg point (AccelBand)- randomized arm
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.
DEVICETNM at a leg point (AccelBand)- open-label
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.
Sponsors
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The randomized 4-week treatment period will be double-blinded for TNM and sham-TNM except for the study coordinator. Participants are unblinded at the 4-week post treatment visit. Of note, sham participants have the option of having a 2-week open label of treatment following the randomized treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Traumatic or non-traumatic spinal cord injury (SCI) * SCI level above the twelfth thoracic vertebra (T12) * SCI classified as Sensory Incomplete (AIS B), C, or D * Post-SCI time ≥ 6 months; * Neurogenic bowel dysfunction (NBD) as a result of SCI * Willing to sign the informed consent form
Exclusion criteria
* Significant cognitive impairment, impeding the ability to provide informed consent or complete the questionnaire * Prior gastrointestinal surgeries other than uncomplicated appendectomies, cholecystectomy or cesarean sections * Known diagnosis of diabetes mellitus * Known current or past severe significant psychiatric disorder * Known current substance abuse * Implanted medical devices for electrical stimulation (e.g. cardiac pacemaker) * Taking opioid medications on a regular daily basis * Currently pregnant or actively planning a pregnancy * Active inflammatory bowel disease * Ventilator dependency * Severe autonomic dysreflexia * No preservation of the sacral spinal reflexes: bulbocavernosus, patella, or Achilles * Complete absence of sensation in the leg (since it is needed for calibrating the TNM intensity)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Neurogenic Bowel Dysfunction (NBD) score | Baseline (phase-in) to 4-week visit | 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. |
| Prolonged colonic transit measurement to assess NBD severity | Baseline and approximately the 4-week post treatment visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Medication use for neurogenic bowel use | Baseline (phase-in) to 4-week visit | Use of medications: name, dose, frequency of medications and duration. |
| Bowel routine techniques | Baseline (phase-in) to 4-week visit | Duration and types of bowel routine techniques will be tracked by the bowel diary application (app). |
| Number of bowel movements per week | Baseline (phase-in) to 4-week visit | This will be tracked by the bowel diary application (app). |
| Bristol stool form scale (BSFS) | Baseline (phase-in) to 4-week visit | 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. |
| SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD) | Baseline (phase-in) to 4-week visit | 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. |
| Gastrointestinal Symptom Rating Scale (GSRS) | Baseline (phase-in) to 4-week visit | 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. |
| Number of Adverse events (serious and non-serious) | Baseline to post treatment visit (approximately 4 weeks) | 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 |
| Fecal loading in the colon | Baseline and approximately the 4-week post treatment visit | 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. |
| Anorectal Manometry Test (AMT) - sensory thresholds | approximately 4-week post treatment visit | 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. |
| Anorectal Manometry Test (AMT) - rectal inhibitory reflex | approximately 4-week post treatment visit | This will be assessed at the clinic with anorectal manometry (ARM). |
| Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain | approximately 4-week post treatment visit | This will be assessed at the clinic with Anorectal manometry (ARM). |
| Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction | approximately 4-week post treatment visit | This will be assessed at the clinic with Anorectal manometry (ARM). |
Countries
United States
Contacts
CONTACTCaitlyn Fisher
PRINCIPAL_INVESTIGATORGianna Rodriguez, MD
University of Michigan
Outcome results
None listed