Spinal Cord Stimulation to Augment Activity Based Therapy
Condition: Transcutaneous Spinal Stimulation; Walking; Spasticity; Human; Spinal Cord Injuries
MeSH terms: Muscle Spasticity; Spinal Cord Injuries
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Transcutaneous spinal stimulation
Intervention type(s): Device
Intervention description(s): For TSS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz.
Other intervention name(s): TSS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment