Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial
The University of Texas Health Science Center, Houston
Summary
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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. Exclusion Criteria: * Ongoing/active genitourinary oncologic diagnoses * History of other central nervous system disorder (CNS) disorders a…
Interventions
- DeviceiTNS
The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.
- DeviceSham iTNS
The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas