Kessler Foundation
The purpose of this study is to investigate treating severe spasticity in persons with spinal cord injury by implanting a device in the body that delivers electrical stimulation around the spinal cord (spinal cord epidural stimulation). This study will be closely monitoring a program designed to treat spasticity using an epidural stimulator to better understand its effects on spasticity and voluntary movement.
This study aims to expand our 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) who are not adequately treated with oral pharmacological management, while avoiding side effects, and also improving voluntary control using surgically implantable targeted tonic spinal cord epidural stimulation (scES). Individuals recruited and enrolled in the study will have significant spasticity not adequately treated by oral medications. Current treatment of severe spasticity…
Inclusion Criteria: 1. At least 22 years of age 2. Post 1 year non-progressive SCI 3. Stable medical condition (cleared by the study physician and do not have any medical conditions that would interfere with study procedures) 4. Diagnosed with and treated for severe spasticity at least 6 months ago Exclusion Criteria: 1. ventilator dependent 2. untreated painful musculoskeletal dysfunction, fracture or pressure injury 3. untreated psychiatric disorder or ongoing drug abuse 4. cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI 5. Botulinum toxin injecti…
Participants will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity.
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