Spinal Cord Stimulation to Augment Activity Based Therapy

Involuntary muscle activity, often referred to as spasticity, is a common problem following spinal cord injury. Spasticity can be evoked by stimuli or occur spontaneously, and it can manifest as spasms, clonus, or the stiffness associated with hypertonia. While medications are typically used to treat the general symptoms of spasticity, they often have additional side effects, like muscle weakness, that can impede rehabilitation. Physical therapeutics offer an alternative to these drug treatments, but the most effective therapeutic strategy for managing spasticity has not yet been identified. A combination of physical therapeutics may provide the best strategy for managing spasticity while also improving general motor control for functional movements.

Walking ability can be improved through locomotor training, which has also been shown to reduce spasticity. When locomotor training is combined with electrical stimulation, the benefits of training may be increased. To investigate the potential benefits of this combinatorial treatment strategy, investigators will use a kind of electrical stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate spinal cord nerves during locomotor training.

In order to facilitate the translation of study findings into clinical practice, this study uses a pragmatic design, meaning that the study will involve the use of real world clinical settings and practices. Participants will undergo their standard physical therapist directed locomotor training program while receiving transcutaneous spinal cord stimulation (TSS) as an additional treatment. The effects of locomotor training alone will be compared to the combination of locomotor training with TSS, specifically comparing the effects of these treatments on spasticity and walking function.

Investigators expect that the combination of TSS with locomotor training will provide 1) a greater reduction in spasticity and 2) a greater improvement of walking function compared to locomotor training alone.

The findings from this study have the potential to rapidly facilitate the translation of a novel combination treatment for the management of spasticity and improvement of walking function into real world clinical practice.

Inclusion criteria

• 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

Exclusion criteria

• 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