Purpose

The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • SCI performing IC
  • Up to 2 anticholinergic overactive bladder (OAB) medications
  • No changes in OAB medications
  • Neurologic level of injury above T10
  • English and Spanish speaking

Exclusion Criteria

  • Past history of genitourinary diagnoses or surgeries
  • History of central nervous system (CNS) disorders and/or peripheral neuropathy
  • Pregnancy
  • Lower motor neuron bladder
  • Concern for tibial nerve pathway injury
  • Absence of toe flexion or AD with electric stimulation
  • Bladder chemodenervation in past 6 months

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
randomized sham-control trial
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The Study is designed to look at the difference in "high dose" group, which will be submotor amperage, compared to "low dose" which will be set to 1 mA. Both groups will need to stimulate the tibial nerve and visualize toe movement, and then decrease to the amperage of either "high dose" or "low dose." Both groups will use the device for 30 minutes, 5 days per week. A urodynamic study will be performed to measure bladder capacity, sensations while filling, and detrusor pressures before starting using the device and one last time at the end of the study. We are also conducting surveys to describe differences in preferences with using bladder medications versus devices.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
High Dose
  • Device: High Dose
    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 the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
    Other names:
    • TTNS stimulation
Other
Control
Low dose TTNS
  • Device: Low dose
    Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
    Other names:
    • TTNS stimulation

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Stampas Argyrios, MD
713-797-5938
argyrios.stampas@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Argyrios Stampas, MD
713-797-5938
argyrios.stampas@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.