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New treatment option for Spinal Cord Injury (SCI)
Official title Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
ClinicalTrials.gov ID: NCT07264868
What this study is testing
- What it's testing
- The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Non-progressive chronic (\>1 year) SCI
- Neurologic level of injury T9 and above
- Stable over active bladder (OAB) medications (≥3 months)
- No contraindication to MRI (per MRI Safety Questionnaire)
- English or Spanish speaking
You likely can't join if
- Ongoing/active genitourinary oncologic diagnoses
- History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
- Pregnancy or planning to become pregnant.
- Lower Motor Neuron bladder
- Restorative bladder surgery such as augmentation cystoplasty
- Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)
See the full eligibility criteria
- Non-progressive chronic (\>1 year) SCI
- Neurologic level of injury T9 and above
- Stable over active bladder (OAB) medications (≥3 months)
- No contraindication to MRI (per MRI Safety Questionnaire)
- English or Spanish speaking
- Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)
- Pass the tTNS competency checklist to perform or direct performance of tTNS.
- Ongoing/active genitourinary oncologic diagnoses
- History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
- Pregnancy or planning to become pregnant.
- Lower Motor Neuron bladder
- Restorative bladder surgery such as augmentation cystoplasty
- Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)
- Anticoagulation treatment or prophylaxis
- Advanced peripheral vascular disease (gangrene, amputation, etc.)
- History of intolerance to electrical stimulation, particularly of the leg
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.