NCT06214208

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

Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shepherd Center, Atlanta GA · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 injury. The spinal stimulation consists of electrical stimulation applied through one electrode over the skin of the lower back and two electrodes over the stomach. Testing will include participating in measurements before the intervention, during intervention, and immediately after the intervention. This study requires participants to come into Shepherd Center 4 consecutive days a week for 2-3 hours per day across 2-3 weeks.

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 the negative side effects of drug therapies. Although research in TSS is growing, the best dosage of TSS remains unknown. The investigators want to further advance the effects of TSS by comparing three different frequencies. Frequency is the number of electrical pulses that are delivered over a period of time. Frequency can affect the activation of nerves and therefore affect the outcome of TSS. Participation in this study includes testing of the participants' spasticity, strength, and pain before and after 30 minutes of TSS.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
OTHER	Transcutaneous Spinal Stimulation	Transcutaneous spinal stimulation will be delivered for 30 minutes using biphasic pulses. A single cathode electrode will be placed over the skin of the back spine at the T11/T12 spinous interspace. Two reference electrodes will be placed over the stomach. Stimulation intensity will be set to 0.8x reflex threshold, as determined by posterior root muscle reflex testing before the intervention. Treatments will be a minimum of 72 hours apart.

Timeline

• Start date: 2024-02-19
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2024-01-19
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States