Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Central Nervous System Diseases
- Nervous System Diseases
- Spinal Cord Diseases
- Spinal Cord Injuries
- Trauma Nervous System
- Wounds and Injuries
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This study will compare the benefits of transcutaneous and epidural stimulation in individuals with SCI through a phased intervention program including: 1) baseline testing, 2) PT only, 3) PT + TransQ stimulation, 4) wash out/recovery, 5) PT + Epidural stimulation, 6) follow-up testing.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 70 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04043715
- Collaborators
- U.S. National Science Foundation
- Investigators
- Principal Investigator: Rajiv Saigal, MD, PhD University of Washington
Get Well Soon