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...
Type
Details
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.
Main benefits
Spasticity
Additional benefits
Standing/walking/mobility
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn moreWings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more