BridgeMD
New treatment option for Spinal Cord Injury
Official title Combined Tibial Nerve Stimulation and Standing for People With SCI
ClinicalTrials.gov ID: NCT07429305
What this study is testing
- What it's testing
- The goal of this clinical trial is to understand how sensory inputs from the lower leg can influence pelvic floor muscle function and urogential function in adults with chronic spinal cord injury (SCI). The main questions it aims to answer are: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- At least 19 years of age
- Have a SCI between C7 - T10 that occurred at least 12 months previously
- Have a motor-complete or incomplete SCI (AIS A, B, C, or D)
- Have symptoms of neurogenic LUT dysfunction
- Meet the manufacture requirements for standing frame use (will be evaluated by the research team)
You likely can't join if
- Have changed their bladder management program in the past month
- Have received an injection of Botulinum toxin-A in any LUT structure in the past 2 weeks, or intend to receive an injection while participating in...
- Have a non-stable SCI (e.g. spinal tumor)
- Have signs of a lower motoneuron injury (e.g. cauda equina syndrome)
- Have other neurological injury besides SCI
- Have an implanted metallic or electronic device (e.g. pace maker, nerve stimulator)
See the full eligibility criteria
- At least 19 years of age
- Have a SCI between C7 - T10 that occurred at least 12 months previously
- Have a motor-complete or incomplete SCI (AIS A, B, C, or D)
- Have symptoms of neurogenic LUT dysfunction
- Meet the manufacture requirements for standing frame use (will be evaluated by the research team)
- Are able to speak and understand English.
- Have changed their bladder management program in the past month
- Have received an injection of Botulinum toxin-A in any LUT structure in the past 2 weeks, or intend to receive an injection while participating in the trial
- Have a non-stable SCI (e.g. spinal tumor)
- Have signs of a lower motoneuron injury (e.g. cauda equina syndrome)
- Have other neurological injury besides SCI
- Have an implanted metallic or electronic device (e.g. pace maker, nerve stimulator)
- Have a condition for which exercise or transcutaneous stimulation is contraindicated
- Have a severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections...
- Are currently pregnant or have given birth within the past 12 months
- Use walking as your primary means of movement around your home and the community.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. 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.