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Spinal Cord Stimulation to Augment Activity Based Therapy

NCT03240601 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-01-25

Study results available
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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.

Conditions

  • Transcutaneous Spinal Stimulation
  • Walking
  • Spasticity
  • Human
  • Spinal Cord Injuries

Interventions

DEVICE

Transcutaneous spinal stimulation

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.

Sponsors & Collaborators

  • Foundation Wings For Life

    collaborator OTHER

  • Shepherd Center, Atlanta GA

    lead OTHER

Principal Investigators

  • Edelle C Field-Fote, PT, PhD · Shepherd Center, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-09-11
Completion
2019-09-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03240601 on ClinicalTrials.gov