Influence of Transcutaneous Spinal Cord Stimulation Intensity on Spasticity After SCI

Clinical Trial ID: NCT04243044

Description

Transcutaneous spinal cord stimulation (tcSCS) is a form of electrical stimulation delivered over the skin of the spine that may be valuable for reducing spasticity without the side effects of antispasticity medications. The intensity of stimulation, or dose, that promotes the best response is not known. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects tcSCS as a non-drug intervention for spasticity management.

Spasticity involves involuntary muscle activity in persons with spinal cord injury (SCI) that can include increased response to muscle stretch and physical touch, as well as muscle stiffness. Due to the combination of symptoms, several drug therapies are currently prescribed to reduce spasticity but they may have negative side effects including fatigue and muscle weakness. Transcutaneous spinal cord stimulation (tcSCS) is a form of electrical stimulation delivered over the skin of the spine to that seem to have effects that are similar to drug therapy. Prior studies of tcSCS in persons with SCI suggest that tcSCS can reduce spasticity without negative side effects. The intensity of stimulation, or dose, that promotes the best response is not known. In addition sensitive measurements are necessary to assess the changes that can be seen in multiple presentations of spasticity. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects tcSCS as a non-drug intervention for spasticity management.


Criteria

Inclusion Criteria: - Ability and willingness to consent and authorize use of protected health information (PHI) - Be between 18-65 years of age - Have a spinal cord injury of any injury severity (AIS A, B, C, or D) - Have at least mild "spasticity" affecting lower extremity muscles - I may use prescription medications if the dosage has not changed in the last 2 weeks Exclusion Criteria: - Inability or unwillingness to consent and authorize use of PHI - Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord - Neurologic level below spinal level T12 - History of cardiovascular irregularities (e.g. atrial fibrillation) - Problems with following instructions - Orthopedic pathology that would limit 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 spinal stimulation - Persons who have implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g. baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator) - Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment

  • Start Date

    2020-01-20

  • Last Updated

    2020-01-23

  • Sponsor

    Shepherd Center, Atlanta GA

  • Condition Name

    Spinal Cord Injuries

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