Overview
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.
Description
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 by pharmacological treatments are associated with several concomitant side effects that have consequences including limiting the ability to participate in and respond to neurorehabilitation and diminishing quality of life. Also, for persons with SCI and severe spasticity, available rehabilitation therapies are limited in their ability to foster appropriate neural excitation and subsequently motor recovery.
This study focuses on ameliorating severe spasticity through specific spasticity-targeted spinal cord epidural stimulation (SP-scES) that has been shown to mediate levels of neural excitation for movement and unwanted muscle activation. In the long-term, this study will also provide a framework to develop clinically viable approaches with tools to provide optimized care for individuals with chronic SCI. This research is directly aimed to improve the quality of life for those affected by and living with SCI by reducing spasticity (and increasing voluntary control of movement) in the home and community.
Participants will be asked to undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to find the specific stimulation configurations for their spasticity. The intervention portion of the study consists of using the stimulator at home and/or in the training facility and completing assessments. Participants will return for follow-up assessments at 3- and 6-months post-intervention. At the conclusion of the study, participants can choose to have the stimulator removed, turned off, or continue using it at home for spasm management.
Eligibility
Inclusion Criteria:
- At least 22 years of age
- Post 1 year non-progressive SCI
- Stable medical condition (cleared by the study physician and do not have any medical conditions that would interfere with study procedures)
- Diagnosed with and treated for severe spasticity at least 6 months ago
Exclusion Criteria:
- ventilator dependent
- untreated painful musculoskeletal dysfunction, fracture or pressure injury
- untreated psychiatric disorder or ongoing drug abuse
- cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI
- Botulinum toxin injections (such as Botox) or other injections to manage spasms (such as phenol or alcohol) in any muscle or bladder less than 6 months prior to implant
- colostomy bag, urostomy
- Any active implantable devices or implanted pump (such as a baclofen pump, pain pump, etc.)
- pregnant at the time of enrollment or planning to become pregnant during the time course of the study
- Contraindications to MRI imaging (e.g., pacemaker, metallic foreign body, aneurysm clip)
- Imaging findings that determine the area of spine the stimulation device would be implanted is not suitable for surgery (such as implanted hardware interference or additional deterioration/injury of spinal cord at or below the region)
- Severe muscle contractures
- unable to operate a touch screen
