N/A
N=18
Spinal Cord Stimulation to Augment Activity Based Therapy
Transcutaneous Spinal Stimulation · Walking · Spasticity · Human · Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03240601 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Change in Walking Function - 10m Walk Walking Speed (m/s) — 0.06; 0.16 speed difference in meters per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous spinal stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shepherd Center, Atlanta GA
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Walking Function - 10m Walk Walking Speed (m/s) |
0.06; 0.16 | — |
| PRIMARY Change in Spasticity - Pendulum Test |
7; 7 | — |
| SECONDARY Change in Walking Function - 2 Minute Walk |
7; 15 | — |
| SECONDARY Change in Spasticity - Ankle Clonus Drop Test |
1; 1 | — |
| SECONDARY Change in Spasticity - Muscle Co-contraction During Voluntary Activation |
1; 1 | — |
| SECONDARY Change in Spasticity - Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Test |
0; 0 | — |
| SECONDARY Stimulation Tolerability |
3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03240601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.