Spinal Cord Stimulation to Augment Activity Based Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Orthopedic, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/12/2018 |
| Start Date: | July 1, 2017 |
| End Date: | July 2019 |
| Contact: | Stephen P Estes, PhD |
| Email: | stephen_estes@shepherd.org |
| Phone: | 4046034967 |
Combined Influence of Transcutaneous Spinal Cord Stimulation and Locomotor Training on Spasticity and Walking Outcomes After Spinal Cord Injury
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 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 ("tcSCS") to stimulate participants' spinal cord nerves during locomotor
training.
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 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 ("tcSCS") to stimulate participants' spinal cord nerves during locomotor
training.
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 ("tcSCS") 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 (tcSCS) as
an additional treatment. The effects of locomotor training alone will be compared to the
combination of locomotor training with tcSCS, specifically comparing the effects of these
treatments on spasticity and walking function.
Investigators expect that the combination of tcSCS 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.
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 ("tcSCS") 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 (tcSCS) as
an additional treatment. The effects of locomotor training alone will be compared to the
combination of locomotor training with tcSCS, specifically comparing the effects of these
treatments on spasticity and walking function.
Investigators expect that the combination of tcSCS 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
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