Effects of spinal stimulation on muscle control and pain in spinal cord injury patients
Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)
This study is testing how different types of spinal stimulation can help people with spinal cord injuries improve muscle control and reduce pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Shepherd Center, Atlanta GA Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06214208 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how different frequencies of noninvasive spinal stimulation affect spasticity, muscle strength, and pain in individuals with spinal cord injuries. Participants will receive transcutaneous spinal stimulation (TSS) through electrodes placed on their lower back and stomach, with assessments conducted before, during, and after the intervention. The study will take place over 2-3 weeks, requiring participants to attend sessions four times a week for 2-3 hours each. The goal is to determine the optimal frequency of TSS to maximize its therapeutic effects.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older who have experienced a spinal cord injury at least three months prior and exhibit some level of spasticity in their legs.
Not a fit: Patients with progressive spinal conditions, certain heart issues, or those with injuries below T12 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of spasticity and pain for patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown promising results with transcutaneous spinal stimulation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Atlanta, Georgia
- Shepherd Center, Inc. — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Edelle C Field-Fote, PT, PhD — Shepherd Center, Atlanta GA
- Study coordinator: Jaclyn Miller, PT, DPT
- Email: jaclyn.miller@shepherd.org
- Phone: 404-350-7638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.