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"Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"
Sponsor: Kessler Foundation
Summary
This study aims to expand the knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal cord injury (SCI). The purpose of this study is to compare if spinal cord epidural stimulation can treat severe spasticity more effectively and have fewer side effects than a baclofen pump.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-07-14
Completion Date
2026-05-15
Last Updated
2022-06-16
Healthy Volunteers
No
Conditions
Interventions
Epidural implant stimulation device
Individuals randomized to the Baclofen pump device group will continue with their clinical surgical and maintenance plan while also participating in all of the outcomes (assessments). The epidural implant group will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity.