Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
NCT07264868 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-05-11
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.
Conditions
- Spinal Cord Injury (SCI)
- Neurogenic Bladder (NB)
Interventions
- DEVICE
-
iTNS
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.
- DEVICE
-
Sham 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.
Sponsors & Collaborators
-
Congressionally Directed Medical Research Programs
collaborator FED -
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
Argyrios Stampas, MD · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-07
- Primary Completion
- 2028-09-01
- Completion
- 2028-09-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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