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AccelBand for Neurogenic Bowel Dysfunction in Spinal Cord Injury

This study is testing a wearable device called AccelBand to see if it can help people with spinal cord injuries (SCI) who experience neurogenic bowel dysfunction (NBD), which causes slow digestion and constipation. The AccelBand uses transcutaneous neuromodulation (TNM), a non-invasive way to stimulate nerves. Researchers want to know if using AccelBand on a leg point reduces NBD symptoms more than using it on a sham-point (a spot not expected to have an effect). You might be able to join if you are 18 or older, have a spinal cord injury above T12 that happened at least 6 months ago, and have NBD. The study will measure changes in your NBD symptoms to see if the treatment is successful. The current status of this study is unclear.

Study design
This is an interventional study with 100 planned participants. It involves a randomized comparison between active AccelBand treatment and a sham treatment, followed by an open-label option for some participants.
What's involved
You would self-administer the AccelBand device twice daily for 60 minutes over approximately 4 weeks. There will be weekly phone calls from the study team and visits at baseline and around 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at baseline and approximately 4 weeks after treatment.

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NCT07171489

Efficacy of a Wearable Noninvasive Neuromodulation Device

Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~100 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:TNM at a sham-point (AccelBand) - randomized armTNM at a leg point (AccelBand)- randomized armTNM at a leg point (AccelBand)- open-label

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Neurogenic Bowel Dysfunction (NBD) score
Measured over Baseline (phase-in) to 4-week visit
+1 more outcome measured

Conditions

Spinal Cord Injuries

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Neurogenic bladder dysfunctionSpinal Cord Injury

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Gianna Rodriguez, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Caitlyn Fisher
[email protected]
734-998-7285
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • The Neurogenic Bowel Dysfunction (NBD) scoreBaseline (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 severityBaseline 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.