NCT04043715

Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function

Spinal Stimulation for Standing & Walking; Comparison of Transcutaneous & Epidural Stimulation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Incomplete spinal cord injuries (SCI) are the most frequent neurologic category, comprising 66.7% of all SCI cases. People with incomplete SCI may retain some ability to move the legs and therefore the capacity to regain walking. Studies that show functional improvement in locomotion via electrical stimulation of lumbosacral circuits suggest that the underlying mechanisms are neuromodulation of lumbosacral spinal cord automaticity and sensory feedback. Both epidural and transcutaneous spinal stimulation are demonstrating exciting potential to improve limb function for people after chronic SCI. Available treatment options for SCI are less than satisfactory and most often do not achieve full restoration of function. Recent experimental results suggest an exciting new approach of using electrical spinal stimulation to enable users to regain control of their weak or paralyzed muscles. Using surgically-implanted electrodes, epidural stimulation results in remarkable improvements of lower extremity function as well as autonomic functions such as bladder function and sexual function. In addition to epidural stimulation, over only the last few years a novel strategy of skin surface electrical spinal stimulation has also demonstrated exciting potential for improving walking function. Using a high-frequency stimulation pulse, current can pass through the skin without discomfort and activate the spinal cord; this results in patterned stepping movements for people without SCI and improved lower extremity function following SCI. This study will directly compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function.

Detailed description

The purpose of this study is to determine the optimal method for delivering spinal stimulation to improve walking in people with incomplete spinal cord injury. By directly comparing non-invasive transcutaneous (TransQ) stimulation with implanted epidural stimulation, investigators hope to guide the field toward the most beneficial method for restoration of lower extremity function. In addition, the investigators may identify subgroups of people that respond better to each type of stimulation, informing personalized treatment for people with different types of spinal cord injury. The research team will explore the following specific aims: Aim 1: Evaluate the improvements in lower extremity and autonomic function via transcutaneous spinal stimulation and intensive physical therapy for people with chronic SCI. Aim 2: Quantify additional improvements in lower extremity and autonomic function via epidural spinal stimulation and intensive physical therapy for people with chronic SCI. The investigators will test the hypothesis that epidural stimulation leads to greater improvements than an equal dose of transcutaneous stimulation. To compare these 2 stimulation methods the study team will evaluate voluntary control of muscle activity via EMG and kinematic parameters of locomotion, as well as improvements in bladder and other autonomic functions and overall quality of life.

Conditions

• Spinal Cord Injuries
• Spinal Cord Diseases
• Central Nervous System Diseases
• Nervous System Diseases
• Trauma, Nervous System
• Wounds and Injuries

Interventions

Type	Name	Description
DEVICE	Transcutaneous spinal stimulation	Physical therapy to improve standing and walking
DEVICE	Epidural spinal stimulation	Physical therapy to improve standing and walking

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2019-08-02
• Last updated: 2024-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study