NCT04074616

Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

• Chronic Spinal Cord Injury
• Neurogenic Bladder

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2019-11-19
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2019-08-30
• Last updated: 2024-10-15
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study