Researchers study wearable technology as part of national stroke recovery clinical trial
KU Medical Center experts are testing the effectiveness of a wearable device at reducing disability after stroke
A clinical trial at the University of Kansas Medical Center is testing whether a wearable device that stimulates the brain and spinal cord with electromagnetic energy might one day help decrease disability after a stroke.
As part of the EMAGINE™ clinical trial, researchers are investigating if stimulating neurons in the brain while performing therapeutic exercise improves recovery after moderately severe ischemic stroke. KU Medical Center is one of 20 sites nationally expected to participate in this randomized, double-blind study that pairs frequency-tuned electromagnetic field therapy with therapeutic exercise.
Frequency-tuned electromagnetic field therapy delivers a low level of electromagnetic stimulation to the brain and spinal cord through a portable wearable device that fits over the head and torso. The trial is studying the effectiveness of the noninvasive wearable device at reducing disability after stroke and helping stroke survivors recover function of their upper and lower body extremities. It is funded by BrainQ, the technology company that developed the investigational device which received FDA Breakthrough Device Designation.
“There’s a theoretical window after stroke when the brain is plastic, or it can change, grow and recover, and we know from other research that the window is a great opportunity for rehabilitation,” said Sarah Eickmeyer, M.D., associate professor of physical medicine and rehabilitation at KU Medical Center and site co-primary investigator. “With this study, we’re hoping to accelerate that neuroplasticity with the electromagnetic stimulation.”
Eligible study participants will be issued either an investigational device or a placebo device (known as a sham device) between four and 21 days after a stroke. The device is designed to allow participants to perform therapy whether in the hospital, in a rehabilitation facility, or at home with the assistance of a trained caregiver, joined periodically by a member of the study team through a remote platform. While receiving poststroke standard of care including physical therapy and occupational therapy, participants will wear the device as they perform intensive exercise five times a week over nine weeks for a total of 45 sessions. Each exercise session will last 60 minutes.
KU plans to enroll up to 12 participants in the study. Eligible participants will be identified through The University of Kansas Health System, which partners with KU Medical Center and provides patient care.
A unique study
Beyond testing the novel approach to stroke recovery, Sandra Billinger, Ph.D., professor and vice chair for stroke translational research in the Department of Neurology and the site co-primary investigator, called the EMAGINE™ study unique because it follows participants through a range of transitions of care.
“In this study, we’re starting the therapy while participants are still hospitalized in the acute phase, then to inpatient stroke rehabilitation and extending it through nine weeks post-stroke while at home. We hope we find that it optimizes recovery, reduces disability and eventually gives us a better map for stroke rehabilitation and recovery in the future,” Billinger said.
The other unusual aspect of the study, Eickmeyer said, is its recognition that stroke recovery and rehabilitation takes time.
“I think this study is so unique because it acknowledges this is a process that takes weeks, not days, and provides continuity of care across the spectrum, which is what people need and what we struggle to provide in our society’s fragmented healthcare system,” she said. “This study could point us toward a model of what stroke recovery should look like in the future, where it continues for months because that’s when the brain recovers and that’s how long the brain needs stimulation and exercise.”
Advancing stroke research
According to the U.S. Centers for Disease Control, in addition to being a leading cause of death in the United States, stroke is a leading cause of long-term disability and reduced mobility in more than half of survivors 65 and over. These stark facts highlight the importance of stroke recovery studies like the EMAGINE™ trial.
“There is a recognition that advances in stroke recovery are the next frontier in stroke research. This is where we really need to be, and KU Medical Center has an opportunity to be a part of that,” Billinger said. “We’re proud to partner with The University of Kansas Health System to provide elite patient care and bring truly groundbreaking research opportunities to people after stroke in the Kansas City area.”