CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Transcutaneous Tibial Nerve Stimulation +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/NCT02573402
NCT02573402N/ACompleted
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The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury

The University of Texas Health Science Center, Houston·interventional·Posted Oct 9, 2015·Updated Sep 10, 2018

In Brief

A clinical study evaluating Transcutaneous Tibial Nerve Stimulation and Control for Spinal Cord Injury and Neurogenic Bladder. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury, Neurogenic Bladder
CountriesUnited States
CollaboratorsThe Institute for Rehabilitation and Research (TIRR), Baylor College of Medicine, Case Western Reserve University, University of Houston

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 9, 2015
Enrollment StartJul 12, 2016
Primary CompletionOct 27, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.7 years ago

Interventions

Transcutaneous Tibial Nerve Stimulationdevice

10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch 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. Current intensity may vary from patient to patient and will be documented and used in the analysis.

Controldevice

10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.