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Spinal Stimulation for Spasticity and Pain After Spinal Cord Injury

This study is looking at how different types of Transcutaneous Spinal Stimulation (TSS) affect spasticity (involuntary muscle activity), muscle strength, and pain in people who have had a spinal cord injury. TSS is a non-invasive electrical stimulation applied to the skin of your lower back and stomach. Researchers want to find out which frequency (number of electrical pulses) works best to reduce spasticity without the side effects of medications. You may be able to join if you are 16 or older, have had a spinal cord injury at least 3 months ago, and have measurable spasticity in your legs. The study will measure spasticity using a Pendulum Test to see how well the stimulation works. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 36 participants. It aims to compare three different frequencies of Transcutaneous Spinal Stimulation.
What's involved
You would visit the Shepherd Center for 4 consecutive days a week, for 2-3 hours per day, over 2-3 weeks. This includes measurements before, during, and immediately after the stimulation.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, the Pendulum Test, is measured at 15 minutes after the intervention. Beyond this, follow-up is not specified.

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NCT06214208

Influence of Spinal Stimulation Frequency on Spasticity, Motor Control, and Pain After Spinal Cord Injury

Recruiting
NAAges 16+InterventionalTreatment
Shepherd Center, Atlanta GA
~36 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Transcutaneous Spinal Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pendulum Test
Measured over 15 minutes

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Edelle C Field-Fote, PT, PhD · PRINCIPAL_INVESTIGATOR · Shepherd Center, Atlanta GA

Who to contact

Jaclyn Miller, PT, DPT
[email protected]
404-350-7638
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Pendulum Test15 minutes

    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.