Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder (TTNS1yr)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    120
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 7 October 2022
electrical stimulation
spinal cord
spinal cord disorder
paraplegia
neurogenic bladder
acute spinal cord injury

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 submotor at current intensity at 1mA and designated as "fixed-dose."

TTNS will be used 5 days weekly, per our pilot trial. 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. 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. All subjects will continue for 1-year post-SCI.

Additionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.

Details
Condition Spinal Cord Injuries
Treatment Variable-dose TTNS Protocol 5 x week, Fixed-dose TTNS Protocol, Variable-dose TTNS Protocol 2 x week
Clinical Study IdentifierNCT04350359
SponsorThe University of Texas Health Science Center, Houston
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

-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
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