Efficacy of a Wearable Noninvasive Neuromodulation Device

NCT07171489 | Not Yet Recruiting FDA Device

• 2 other identifiers: HUM002791261UG3NS125182-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Neurogenic bowel dysfunction; Transcutaneous neuromodulation; Questionnaires; AccelBand; Anorectal manometry test

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and approximately the 4-week post treatment visit

Secondary Outcomes (12)

• 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

Study Arms (2)

Sham (TNM at a sham-point) -Randomized arm

SHAM COMPARATOR

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.

Device: TNM at a sham-point (AccelBand) - randomized arm; Device: TNM at a leg point (AccelBand)- open-label

Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm

EXPERIMENTAL

Participants will have a 2-week phase-in period followed by a 4-week treatment phase.

Device: TNM at a leg point (AccelBand)- randomized arm

Interventions

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.

Sham (TNM at a sham-point) -Randomized arm

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.

Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm

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.

Sham (TNM at a sham-point) -Randomized arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Gianna Rodriguez, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlyn Fisher

CONTACT

734-998-7285; fishercj@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)