Efficacy of a Wearable Noninvasive Neuromodulation Device
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- TNM at a sham-point (AccelBand) - randomized arm
- TNM at a leg point (AccelBand)- randomized arm
- TNM at a leg point (AccelBand)- open-label
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Michigan
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov