CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
4-week TTNS home-based protocoldevice
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/NCT03458871
NCT03458871N/ACompleted
CompareCT.gov

Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation

The University of Texas Health Science Center, Houston·interventional·Posted Mar 8, 2018·Updated Oct 29, 2021

In Brief

A clinical study evaluating 4-week TTNS home-based protocol for Chronic Spinal Cord Injury and Neurogenic Bowel. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in chronic SCI provided by self or caregiver for 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spinal Cord Injury, Neurogenic Bowel
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 8, 2018
Enrollment StartMar 13, 2018
Primary CompletionFeb 6, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.3 years ago

Interventions

4-week TTNS home-based protocoldevice

4-week TTNS home-based 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 not contraction seen, maximal tolerable intensity will be used. In addition, 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.