Toward Effective Pressure Ulcer Prevention: Development of a Flexible Implanted Stimulator for Improved Gluteal Muscle Quality and Regular Weight Shifting
Abstract
Ultimate applicability of the proposed research: The proposed translational project directly addresses a key area of the Fiscal Year 2016 Spinal Cord Injury Research Program: Development, validation, and timing of promising interventions to address consequences of spinal cord injury (SCI). This research could help anyone who experiences a SCI and is at risk of developing pressure ulcers and deep tissue injuries (PU/DTI). These injuries to the skin and underlying tissue are caused by sustained applied pressure on bony areas, i.e., sitting or lying on one spot for extended periods of time. An area of skin damage can rapidly spread to tissues underlying the skin and may cause permanent damage to muscle or bone. The research will develop and test flexSTIM, a small flexible fully implantable stimulator to be used with stimulating electrodes to provide a fully implanted intermittent gluteal stimulation (iGSTIM) system enabling effective regular weight-shifting at the touch of a button. The iGSTIM system will impact fundamental and essential challenges in PU prevention and musculoskeletal health, and ultimately be applicable to all persons with SCI, particularly for those with high levels of injury who have extensive intramuscular fat and/or cannot perform independent pressure relief. What persons with SCI will it help, and how will it help them: Persons with SCI need effective interventions to prevent PU/DTI development and recurrence. Motor impairment causes muscle atrophy that changes both muscle quantity and quality, increasing the risk of PU/DTI. Persons with recurrent PU/DTI are often unable to maintain regular employment or participate actively in community life. Caring for Veterans and military personnel with SCI who develop PU/DTI is costly and time intensive. The only way to heal these wounds is to stay off of the injured area, which can lead to weeks or even months of bedrest. PU/DTI can also become so deep and infected that surgery is the only option, requiring even more bedrest until starting rehabilitation. Thus, PU/DTI can cause emotional distress and significantly impact quality of life. The overall study goal is to prevent PU/DTI in the buttocks by stimulating the gluteal muscles to provide effective weight shifting, increasing muscle bulk and reducing intramuscular fat. Over a decade ago, our team implanted systems that provided iGSTIM in five individuals with SCI and successfully provided pressure relief and exercise. While iGSTIM was used regularly, these individuals did not develop PU/DTI and actually regained healthy tissue under the skin and increased their gluteal muscle mass. However, the original system included wires that came through the skin to connect to an external control box, leaving small holes in the skin that were difficult to keep covered and clean and were susceptible to infection. Our team has been contacted many times over the years by individuals asking for a system that could be entirely implanted. Other prevention methods these individuals tried have failed and they are desperate for a new alternative. There is currently no technology that can provide the reliable dynamic iGSTIM needed for regular pressure relief. The project will develop the iGSTIM system, which will be a safe and effective method to improve tissue health and muscle tone to help all persons with SCI by providing weight-shifting at the touch of button. Potential clinical applications, benefits, and risks of this research: This translational project will support the development and testing of flexSTIM, a stimulator that will not interfere with a magnetic resonance imaging (MRI) machine and can be placed during an outpatient procedure. The benefits of the fully implanted iGSTIM system will include increased quality of life and decreased cost of medical care for both the individual and the hospital. Risks will be minimized because only a small incision will be needed to implant the flexibl
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1710149
Entities
People
- Katherine Bogie
Organizations
- Case Western Reserve University
- United States Army