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NOT YET RECRUITING
NCT07264868
NA

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

Official title: Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-02-28

Completion Date

2028-09-01

Last Updated

2026-02-10

Healthy Volunteers

No

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.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States