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.prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.) History of central nervous system disorder (i.e.prostate hypertrophy, overactive bladder, cancer, etc.) History of genitourinary diagnoses (i.e.T9 level of injury and above who are at greatest risk of morbid NGB When is Dorsal Column Spinal Cord Stimulator Used The dorsal column spinal cord stimulator is used for: Pain that persists even after multiple back surgeries (Failed Back Syndrome) Complex Regional Pain Syndrome (RSK & Causalgia) Peripheral Vascular disease and ischemic pain.Admitted to inpatient rehabilitation within 6 weeks. The resource impact would be comparable with standard care, which ranged from £13,726 to £22,418 for a rechargeable spinal cord stimulation system. The trial phase cost ranges from £1,920 to £4,975. Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder The cost of Evoke ranged from £17,595 to £19,395 for the device. The PI and investigators will be blinded to randomization and treatment allocation, managed by the research assistant. Subjects will be randomized to either Variable or fixed-dose (2:1) using a block size of 6 and stratified based on complete/incomplete SCI to ensure the equal allocation of the most severely injured in the two groups. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More InformationĪ prospective, double-blinded, randomized trial. All subjects will continue for 1-year post-SCI.Īdditionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study. Because there is support in the literature for reduced doses of tibial nerve stimulation required for maintenance (1-3x weekly), the RCT includes this frequency comparison arm. At 4-months post-SCI, the subject will be instructed to switch to 2x daily if he or she was randomized into the variable dose group of 2 days weekly and thus continue to doing so for the remainder of study participation. TTNS will be used 5 days weekly, per our pilot trial. The experimental group will use a submotor "variable dose." The fixed-dose group will use submotor at current intensity at 1mA and designated as "fixed-dose." It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly.īased on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. 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.
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