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NCT Number: NCT07171489

Efficacy of a Wearable Noninvasive Neuromodulation Device

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Caitlin Fisher

CONTACT

[email protected]

734-998-7285

Gianna Rodriguez, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TNM at a sham-point (AccelBand) - randomized arm

Device

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.

TNM at a leg point (AccelBand)- randomized arm

Device

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.

TNM at a leg point (AccelBand)- open-label

Device

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.

Primary outcomes

  1. 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.

  2. 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

  1. Daily Medication use for neurogenic bowel use

    Time frame: Baseline (phase-in) to 4-week visit

    Use of medications: name, dose, frequency of medications and duration.

  2. Bowel routine techniques

    Time frame: Baseline (phase-in) to 4-week visit

    Duration and types of bowel routine techniques will be tracked by the bowel diary application (app).

  3. Number of bowel movements per week

    Time frame: Baseline (phase-in) to 4-week visit

    This will be tracked by the bowel diary application (app).

  4. Bristol stool form scale (BSFS)

    Time frame: 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.

  5. SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD)

    Time frame: 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.

  6. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 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.

  7. Number of Adverse events (serious and non-serious)

    Time frame: 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

  8. Fecal loading in the colon

    Time frame: 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.

  9. Anorectal Manometry Test (AMT) - sensory thresholds

    Time frame: 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.

  10. Anorectal Manometry Test (AMT) - rectal inhibitory reflex

    Time frame: approximately 4-week post treatment visit

    This will be assessed at the clinic with anorectal manometry (ARM).

  11. Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain

    Time frame: approximately 4-week post treatment visit

    This will be assessed at the clinic with Anorectal manometry (ARM).

  12. Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction

    Time frame: approximately 4-week post treatment visit

    This will be assessed at the clinic with Anorectal manometry (ARM).

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlyn Fisher

CONTACT

[email protected]

734-998-7285

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 12, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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