Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Washington, D.c.
MedStar National Rehabilitation Hospital
RECRUITING
Washington D.c.
Texas
TIRR Memorial Hermann Research Center
RECRUITING
Houston
Contact Information
Primary
Argyrios Stampas, MD
argyrios.stampas@uth.tmc.edu
713-797-5938
Time Frame
Start Date: 2020-06-08
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 120
Treatments
Active_comparator: Variable-dose TTNS Protocol 5 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.
Active_comparator: Fixed-dose TTNS protocol
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.
Active_comparator: Variable-dose TTNS Protocol 2 x 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.
Related Therapeutic Areas
Sponsors
Collaborators: MedStar National Rehabilitation Network, The Methodist Hospital Research Institute
Leads: The University of Texas Health Science Center, Houston