Neurogenic Bowel Clinical Trials

Find Neurogenic Bowel Clinical Trials Near You

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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Caitlyn Fisher
fishercj@med.umich.edu
734-998-7285
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2029-11
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov