CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
High Dose +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04074616
NCT04074616N/ACompleted
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Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

The University of Texas Health Science Center, Houston·interventional·Posted Aug 30, 2019·Updated Oct 15, 2024

In Brief

A clinical study evaluating High Dose and Low dose for Chronic Spinal Cord Injury and Neurogenic Bladder. Completed, enrolled 50 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spinal Cord Injury, Neurogenic Bladder
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS)

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 30, 2019
Enrollment StartNov 19, 2019
Primary CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.8 years ago

Interventions

High Dosedevice

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.

Low dosedevice

Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes