Trials / Not Yet Recruiting
Not Yet RecruitingNCT07264868
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-02-28
- Primary completion
- 2028-09-01
- Completion
- 2028-09-01
- First posted
- 2025-12-04
- Last updated
- 2026-02-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07264868. Inclusion in this directory is not an endorsement.