Spinal Cord Stimulation to Augment Activity Based Therapy

Completed · Not applicable

Conditions studied: Transcutaneous Spinal Stimulation, Walking, Spasticity, Human, Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT03240601

Run by

Shepherd Center, Atlanta GA

People needed

18

Starts

2017-07-01

Expected to finish

2019-09-11

Last updated by the study team

2022-01-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability and willingness to consent and/or authorize use of protected health information
• Be between 18-65 years of age
• Be enrolled in Spinal Cord Injury In-Patient or Day Program at the Shepherd Center
• Be eligible for locomotor training at the Shepherd Center
• Be able to take a step, with or without an assistive device
• Have a spinal cord injury, completed in-patient rehabilitation, and have been discharged to home
• Have at least mild "spasticity" affecting leg muscles
• You may participate if you use prescription medications, including baclofen for control of spasticity

You may not qualify if…

• Inability or unwillingness to consent and/or authorization for use of protected health information
• Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
• Neurologic level at or below spinal level T12
• History of cardiovascular irregularities
• Problems with following instructions
• Orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
• Women who are pregnant, or who have reason to believe they are or may become pregnant due to unknown risks to the fetus associated with tcSCS
• Persons who have implanted stimulators/electronic devices of any type will be excluded due to unknown potential of tcSCS effects
• Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment

Where it is running

• Shepherd Center, Inc. — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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