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Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
Sponsor: The University of Texas Health Science Center, Houston
Summary
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2020-06-08
Completion Date
2026-07-01
Last Updated
2025-07-14
Healthy Volunteers
No
Conditions
Interventions
Variable-dose TTNS Protocol 5 x week
Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
Fixed-dose TTNS Protocol
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury.
Variable-dose TTNS Protocol 2 x week
At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.
Locations (2)
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
TIRR Memorial Hermann Research Center
Houston, Texas, United States