Efficacy of a Wearable Noninvasive Neuromodulation Device
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)
University of Michigan
100 participants
Jul 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria13
- 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)
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Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07171489