Efficacy of a Wearable Noninvasive Neuromodulation Device
Recruiting
N/A
Interventional Study
Spinal Cord Injuries
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- University of Michigan · Other
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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:
*…
Trial Locations
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Eligibility Criteria
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 …
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