CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Transcutaneous spinal stimulationdevice
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/NCT03240601
NCT03240601N/ACompleted

Combined Influence of Transcutaneous Spinal Cord Stimulation and Locomotor Training on Spasticity and Walking Outcomes After Spinal Cord Injury

Shepherd Center, Atlanta GA·interventional·Posted Aug 7, 2017·Updated Jan 25, 2022

In Brief

A clinical study evaluating Transcutaneous spinal stimulation for Transcutaneous Spinal Stimulation and 4 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Involuntary muscle activity, often called spasticity, is a common problem following spinal cord injury (SCI) that can make it hard to move. Many things can cause spasticity including: muscle stretch, movement, or it can happen for no reason, and it is often described as an uncontrolled muscle spasm or feeling of stiffness. Drugs are typically used to treat spasticity, but they often have side effects, like muscle weakness, which can add to movement problems. Rehabilitation therapies offer alternatives to drugs for treating involuntary muscle activity, and rehabilitation can also improve daily function and quality of life. These benefits may be greater when several rehabilitation therapies are used together. Walking ability can be improved with a type of therapy called "locomotor training". This type of therapy may also have the benefit of decreasing spasticity. When locomotor training (LT) is combined with electrical stimulation, the benefits of training may be increased. In this study, investigators will use a kind of stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate participants' spinal cord nerves during locomotor training.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 7, 2017
Enrollment StartJul 1, 2017
Primary CompletionSep 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.9 years ago

Interventions

Transcutaneous spinal stimulationdevice

For TSS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz.