Status:
RECRUITING
Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury
Lead Sponsor:
Shepherd Center, Atlanta GA
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
16+ years
Phase:
NA
Brief 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 ...
Detailed Description
Transcutaneous spinal stimulation (TSS) is a noninvasive electrical stimulation that is applied over the skin of the low back and stomach. In prior research studies, TSS has reduced spasticity without...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06214208
Start Date
February 19 2024
End Date
December 15 2026
Last Update
October 30 2025
Active Locations (1)
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1
Shepherd Center, Inc.
Atlanta, Georgia, United States, 30309