Recruiting

TNM

Sponsor:

University of Michigan

Code:

NCT07171489

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

TNM at a leg point (AccelBand)- randomized arm

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

Study Details

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

Study ID

NCT07171489

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

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

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

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 outcome measure

  • The Neurogenic Bowel Dysfunction (NBD) score [ Time Frame: Baseline (phase-in) to 4-week visit ]
  • Prolonged colonic transit measurement to assess NBD severity [ Time Frame: Baseline and approximately the 4-week post treatment visit ]

Central Contacts and Locations

Central contacts

Caitlyn Fisher

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

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Caitlin Fisher

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

Principal Investigator:

Gianna Rodriguez, MD

More Information

Sponsor

University of Michigan

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-06.