Transcutaneous Spinal Stimulation for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen ByEdelle C Field-Fote, PT, PhD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Shepherd Center, Atlanta GA

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that may be valuable for reducing spasticity without the side effects of antispasticity medications. The intensity of stimulation, or dose, that promotes the best response is not known. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.

Eligibility Criteria

This trial is for individuals aged 16 or older with any severity of spinal cord injury (SCI) that occurred at least 3 months ago and causes mild to severe spasticity. Participants must be stable on their current medications, able to communicate discomfort, and not have progressive spinal issues, cardiovascular irregularities, active cancer, certain orthopedic limitations, semi-permanent anti-spasmodic treatments like botox, pregnancy, implanted stimulators or active infections.

Inclusion Criteria

I can understand and follow several instructions.

I have mild stiffness in my leg muscles.

I am 16 years old or older.

Exclusion Criteria

I have cancer or have had cancer in the past.

I do not have severe joint stiffness that would stop me from joining.

I use long-term treatments for muscle spasms.

My spinal injury is below the T12 level.

I have a history of heart rhythm problems.

My spine condition is getting worse over time.

I am not pregnant and do not plan to become pregnant during the trial.

I have skin issues that could worsen with treatment.

Participant Groups

The study investigates the effects of Transcutaneous Spinal Stimulation (TSS), a non-drug electrical stimulation therapy applied over the spine skin to reduce spasticity in SCI patients. It aims to determine the optimal intensity level for managing spasticity without medication side effects.

3Treatment groups

Experimental Treatment

Group I: Intensity 3 (0.8x reflex threshold, burst, 30 minute duration)Experimental Treatment1 Intervention

Transcutaneous spinal stimulation will be applied in bursts at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Group II: Intensity 2 (0.8x reflex threshold, dual-site, 30 minute duration)Experimental Treatment1 Intervention

Transcutaneous spinal stimulation will be applied continuously at two sites at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Group III: Intensity 1 (0.8x reflex threshold, continuous, 30 minute duration)Experimental Treatment1 Intervention

Transcutaneous spinal stimulation will be applied continuously at 0.8x reflex threshold as determined from baseline testing of posterior root muscle reflexes.

Transcutaneous Spinal Stimulation is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Transcutaneous Spinal Stimulation for: