With a $3.1 million grant from the U.S. Department of Veterans Affairs (VA), a Case Western Reserve University (CWRU) researcher's quest to transform the quality of life of people living with spinal cord injuries will move closer to a clinical trial.
Kath Bogie, Professor in the Department of Orthopedics in the Case Western Reserve School of Medicine and Research Career Scientist at the Louis Stokes Cleveland VA Medical Center, leads the team that developed the iGSTIM System.
The iGSTIM system includes flexSTIM, an implantable battery-free stimulator controlled by an external remote that could reduce pressure injuries (aka pressure ulcers or bedsores) in people with impaired movement or paralysis by delivering regular muscle stimulation that automatically shifts their weight while sitting or lying down.
Bogie has spent years developing prototypes of the system in partnership with the VA's Advanced Platform Technology (APT) Center, a rehabilitation research and development center that combines research in the engineering and basic science fields to improve the lives of disabled Veterans.
The huge impact of pressure injuries on quality of life is the underlying focus of my career. Recent advances in flexible hybrid electronics, additive manufacturing and packaging lay the foundation for translation of the flexSTIM biomimetic stimulator that, in combination with industry-standard intramuscular electrodes, provides a fully implanted iGSTIM system for regular automated weight-shifting at the touch of a button."
Kath Bogie, Professor, Department of Orthopedics, Case Western Reserve School of Medicine
The VA's Office of Research and Development chose the flexSTIM development for a Stage 2 Translational Development Award, building on previous funding that allowed Bogie's team to create the device.
Now, researchers will create hundreds of devices that will be tested and refined to prepare for U.S. Food and Drug Administration-guided feasibility studies involving 10 Veterans with spinal cord injuries.
Pressure injuries, like bedsores and ulcers, remain a major concern for the estimated 255,000 to 390,000 people in the U.S. living with spinal cord injuries. Because people with spinal cord injuries often have limited mobility and some degree of paralysis, most clinicians recommend some sort of weight shifting every 20 minutes. But people often forget, or are physically unable to move.
Pressure injuries occur when damaged or paralyzed tissue doesn't sense discomfort and send a signal to the brain that it's time to shift their weight-something the average adult does naturally about every 2.5 minutes.
Untreated bedsores can become severe and lead to potentially life-threatening complications, including bacterial infections and sepsis. A global study released last year found that 37,000 died from complications due to pressure injuries in 2021.
The VA has become a leader in this research because it provides lifetime care for about 42,000 military Veterans living with spinal cord injuries.
Most commercially available devices feature either electrodes that are attached to the surface of the skin, or must be inserted into areas with large soft-tissue cushioning like the abdomen. The former can damage the skin and the latter requires major surgery.
Bogie and the VA researchers created the flexSTIM stimulator as an alternative. It's a tiny, flexible device inserted through a one-inch incision made during an outpatient procedure with local anesthesia. The device can, for example, be inserted into the gluteal tissue and deliver electrical stimulation to the muscles that mimics the effect of weight shifting. The benefits are two-fold: the painless stimulation both strengthens the tissue and increases blood flow to the area.
Bogie's team of co-investigators from CWRU and the Cleveland VA Medical Center includes Chris Zorman, Kristi Henzel, Janet Gbur and Doug Shire. The team has also collaborated with Sigenics Inc. CEO Phil Troyk who will develop the flexSTIM electronics and Med-Ally CEO Raja Hitti who will provide specialized system hardware.
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