The goal of this study is to identify the effect of different types of noninvasive spinal stimulation on spasticity (involuntary muscle activity), muscle strength, and pain in people with spinal cord injury. The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach. Testing will include participating in measurements before the intervention, during intervention, and immediately after the intervention. This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks.
Participants must agree to allow use of health information.
Participants should be 16 years old or older.
Participants must have had a spinal cord injury (SCI) of any severity (AIS A, B, C, or D) that happened at least 3 months ago.
Objectively measurable spasticity in your legs.
People with spinal issues that are getting worse, such as degenerative or progressive vascular disorders.
People neurological problems other than SCI.
People with an injury level is below T12.
People with un-treated or uncontrolled heart problems that the lead investigator believes could be affected by stimulation or affected by an increase in blood pressure.
Crossover
Transcutaneous Spinal Stimulation
Other interventionTranscutaneous spinal stimulation will be delivered for 30 minutes using biphasic pulses. A single cathode electrode will be placed over the skin of the back spine at the T11/T12 spinous interspace. Two reference electrodes will be placed over the stomach. Stimulation intensity will be set to 0.8x reflex threshold, as determined by posterior root muscle reflex testing before the intervention. Treatments will be a minimum of 72 hours apart.
Pendulum Test
During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer.
Ankle Clonus Test
During the ankle clonus test, the participant will be seated at the edge of a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's leg above a box and then release the leg allowing the front of the foot to land on the edge of the box. This test will be video recorded and the movement of the ankle joint will be measured using software on the computer.
Muscle activation
Participants will be asked to activate different leg muscles and produce the maximum amount of force possible. Muscle activation will be measured through sensors placed on the muscles and force production will be measured using a dynamometer.
Posterior root muscle reflexes
Posterior root muscle reflexes will be used to measure spinal reflex excitability. These reflexes will also be used to determine the intensity of stimulation that is applied during the intervention (0.8x soleus reflex threshold). During this test, participants have a single electrode over the skin of the back (T11/12) and two electrodes over the stomach (umbilicus). Brief pulses of stimulation will be applied at gradually increasing intensities while measuring muscle responses in different leg muscles.
Nociception/Pain
The investigators will measure nociception using the flexor reflex. The flexor reflex measures muscle responses to an unpleasant stimulus. Electrodes will be placed at the bottom of the foot. First, the investigators will measure muscle responses to a single stimulus (25 mA). Next, the investigators will measure muscle responses to 5 consecutive stimuli (25 mA). The investigators will then ask participants to rate the unpleasant stimulus on a scale of 0-10.
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Shepherd Center, Atlanta GA
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
