Effects of spinal stimulation on muscle control and pain in spinal cord injury patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury

  This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.

  Recruiting TryAbility LLC · Downers Grove, Illinois · NCT07922122

• NG004 for incomplete cervical spinal cord injury

  This trial tests NG004 versus placebo to see if it is safe and helps motor function and daily life in adults with acute incomplete cervical spinal cord injury.

  Recruiting at 7 sites Phase 1 NovaGo Therapeutics AG · Bayreuth and 9 other locations · NCT07840196

• Robot-assisted training for arm and leg movement after stroke or injury

  This study tests whether adding ZEPU-AI robotic training to usual therapy is safe and helps adults with arm or leg movement problems from stroke, spinal cord injury, brain injury, or orthopedic conditions.

  Recruiting Bangladesh Medical University · Dhaka · NCT07749625

• ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab

  This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.

  Recruiting Bangladesh Medical University · Dhaka, Dhaka Division · NCT07705906

• Combined magnetic stimulation and ultrasound for detrusor overactivity in spinal cord injury

  This study tests whether using high-frequency sacral nerve stimulation together with bladder-directed ultrasound can reduce involuntary bladder contractions and improve bladder function in people with spinal cord injury.

  Recruiting Shengjing Hospital · Shenyang · NCT07704268

• Hybrid HIIT-FES cycling program for people with spinal cord injury

  This study tests a hybrid exercise program that combines functional electrical stimulation cycling with voluntary arm work to improve health in adults with spinal cord injury.

  Recruiting William Carey University · Hattiesburg, Mississippi · NCT07648173

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.