Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder (TTNS1yr)
Spinal Cord Injuries
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring electric stimulation, SCI, spinal cord injury, neurogenic bladder
Eligibility Criteria
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 tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.)
- Pregnancy
- Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy
- concern for tibial nerve pathway injury
- absence of toe flexion or autonomic dysreflexia during electric stimulation test
- Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Sites / Locations
- MedStar National Rehabilitation HospitalRecruiting
- TIRR Memorial Hermann Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Variable-dose TTNS Protocol 5 x week
Fixed-dose TTNS protocol
Variable-dose TTNS Protocol 2 x week
TTNS protocol: 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. All participants will be instructed to use the device for 30 minutes, 5 days per week for the first 4 months post-sci.
Fixed-dose protocol: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. Both variable-dose TTNS and fixed-dose TTNS protocol participants will be instructed to use the device for 30 minutes, 5 days per 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.