Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury
Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)
Shepherd Center, Atlanta GA
36 participants
Feb 19, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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.
- Participants must inform the investigators if there is a change in medications during the study.
- Participants must be able to follow instructions.
- Participants must be able to communicate if pain or discomfort is experienced.
Exclusion Criteria13
- 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.
- People with bone or joint problems that would make it hard to follow the study plan.
- Women who are pregnant or actively trying to become pregnant.
- People with implanted stimulators (like a baclofen pump, spinal stimulator, heart defibrillator, or diaphragmatic pacemaker)
- People with infection.
- People with skin that is broken or wounds in the area of the body where stimulation is applied.
- People who have or had certain types of cancer in the area of the body where stimulation will be applied.
- People who have had botulinum toxin or numbing shots in the test leg or spine in the last 6 months
- People who have had permanent spasticity treatment in the test leg or spine (like a certain type of surgery).
- Other health issues that the lead investigator things could make it unsafe for you to join the study.
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Interventions
Transcutaneous 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.
Locations(1)
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NCT06214208