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Completed
NCT04350359
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
Conditions: Spinal Cord Injuries
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 111
Sponsor: The University of Texas Health Science Center, Houston
Location: MedStar National Rehabilitation Hospital Washington D.C. District of Columbia
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.
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
Source: ClinicalTrials.gov (NCT04350359). StuddyBuddy aggregates publicly available trial information.