Efficacy of a Wearable Noninvasive Neuromodulation Device

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07171489
Status
Not Yet Recruiting

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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 30, 2025
Status verified
Sep 2025
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

The Neurogenic Bowel Dysfunction (NBD) score [ Time Frame: Baseline (phase-in) to 4-week visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Caitlin Fisher
[email protected]
734-998-7285
Gianna Rodriguez, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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