Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
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.
Description
The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly. Based on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. The experimental group will use a submotor "variable dose." The fixed-dose group will use subm…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18-75 years old * Traumatic or non-traumatic SCI * Admitted to inpatient rehabilitation within 6 weeks * T9 level of injury and above who are at greatest risk of morbid NGB * Regionally located to allow follow-up * English or Spanish speaking Exclusion Criteria: * History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.) * History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.) * History of peripheral neuropathy * pre-SCI symptoms of peripheral neuropathy (numbness and/or ti…
Interventions
- DeviceVariable-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.
- DeviceFixed-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.
- DeviceVariable-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 HospitalWashington D.C., District of Columbia
- TIRR Memorial Hermann Research CenterHouston, Texas