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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The randomized 4-week treatment period will be double-blinded for TNM and sham-TNM except for the study coordinator. Participants are unblinded at the 4-week post treatment visit. Of note, sham participants have the option of having a 2-week open label of treatment following the randomized treatment.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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.
  • Device: 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.
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.
  • Device: 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.

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Caitlin Fisher
734-998-7285
fishercj@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.