Transcutaneous Spinal Cord Stimulation for Bowel Management in Individuals with Motor Complete Spinal Cord Injury

Launched by NOVA SCOTIA HEALTH AUTHORITY · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new method called transcutaneous spinal cord stimulation to help manage bowel issues in individuals who have suffered a traumatic spinal cord injury. The main goal is to see if this treatment is safe and practical for people who are in rehabilitation after their injury. Participants will receive a daily 30-minute session of stimulation over a 10-day period, and researchers will monitor their bowel function, as well as their overall health and comfort during the sessions.

To be eligible for the trial, participants must be at least 16 years old and have a specific type of spinal cord injury (T10 and above) that is at least three months old. They should also be medically stable and willing to follow the study guidelines. Throughout the trial, participants will keep track of their bowel care routines and satisfaction levels before and after the stimulation sessions. The researchers hope that this new treatment will make bowel care easier and more effective for those involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Individual must have a T10 and above AIS A-B traumatic spinal cord injury
• • 2. Individual must be 16 years or older
• • 3. They must be willing to comply with the study procedure and be medically stable
• • 4. They must be at least 3 months since their injury, to minimize the chances that they are in spinal shock, which may influence the impact of TSCS as the peripheral nerves may be less excitable)
• • 5. There must not be any changes to their bowel medications or bowel regimen in the week leading up to the intervention, to minimize any confounding effect on bowel habits
• • 6. They must have bowel care either daily or q2 days
• Exclusion Criteria:
• • 1. Individuals with a pacemarker, cochlear implant, baclofen pump or other implantable device that may be affected by electrical stimulation.
• • 2. Individuals with epilepsy
• • 3. Individuals with open wounds at stimulation sites
• • 4. Individuals with implanted metal in the trunk and spinal cord at the cathode pad application sites (i.e. T10 to L2)
• • 5. Individuals with a severe acute medical issue that is felt to affect participation at the discretion of the research team, including individuals with uncontrolled autonomic dysreflexia
• • 6. Individuals who are pregnant or planning to become pregnant, and who may be breastfeeding.