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Tests treatment safety and results for Spinal Cord Injuries
Official title Efficacy of a Wearable Noninvasive Neuromodulation Device
ClinicalTrials.gov ID: NCT07171489
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.