An Early Feasibility Study of Using the AccelBand, a Leg-worn Transcutaneous Neuromodulation (TNM) Device, for Neurogenic Bowel Dysfunction (NBD) in People With Spinal Cord Injury (SCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Michigan
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The Neurogenic Bowel Dysfunction (NBD) score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, 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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Sham (TNM at a sham-point) -Randomized arm
Participants will have a 2-week phase-in period.followed by a 4-week sham treatment.
Sham participants can elect to have 2 weeks of open-label treatment once unblinded after 4 weeks of sham.
Intervention: TNM at a sham-point (AccelBand) - randomized arm (Device)
Sham (TNM at a sham-point) -Randomized arm
Participants will have a 2-week phase-in period.followed by a 4-week sham treatment.
Sham participants can elect to have 2 weeks of open-label treatment once unblinded after 4 weeks of sham.
Intervention: TNM at a leg point (AccelBand)- open-label (Device)
Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm
Participants will have a 2-week phase-in period followed by a 4-week treatment phase.
Intervention: TNM at a leg point (AccelBand)- randomized arm (Device)
Outcomes
Primary Outcomes
The Neurogenic Bowel Dysfunction (NBD) score
Time Frame: 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
Time Frame: 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 Outcomes
- Gastrointestinal Symptom Rating Scale (GSRS)(Baseline (phase-in) to 4-week visit)
- Fecal loading in the colon(Baseline and approximately the 4-week post treatment visit)
- Anorectal Manometry Test (AMT) - rectal inhibitory reflex(approximately 4-week post treatment visit)
- Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction(approximately 4-week post treatment visit)
- Daily Medication use for neurogenic bowel use(Baseline (phase-in) to 4-week visit)
- Bowel routine techniques(Baseline (phase-in) to 4-week visit)
- Number of bowel movements per week(Baseline (phase-in) to 4-week visit)
- Bristol stool form scale (BSFS)(Baseline (phase-in) to 4-week visit)
- SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD)(Baseline (phase-in) to 4-week visit)
- Gastrointestinal Symptom Rating Scale (GSRS)(Baseline (phase-in) to 4-week visit)
- Number of Adverse events (serious and non-serious)(Baseline to post treatment visit (approximately 4 weeks))
- Fecal loading in the colon(Baseline and approximately the 4-week post treatment visit)
- Anorectal Manometry Test (AMT) - sensory thresholds(approximately 4-week post treatment visit)
- Anorectal Manometry Test (AMT) - rectal inhibitory reflex(approximately 4-week post treatment visit)
- Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain(approximately 4-week post treatment visit)
- Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction(approximately 4-week post treatment visit)
Investigators
Gianna Rodriguez
Clinical Professor of Physical Medicine and Rehabilitation
University of Michigan