Researchers from Kessler Foundation and Kessler Institute for Rehabilitation (collectively "Kessler") are enrolling participants in a national trial of a breakthrough device for improving recovery after stroke. Kessler locations in West Orange and Saddle Brook, NJ, are among the 20 sites across the U.S. participating in the EMAGINE Stroke Recovery Trial, which pairs therapeutic exercise with stimulation of the brain through an investigational wearable device. Steven Kirshblum, MD, is principal investigator and Ghaith Androwis, PhD is co-primary investigator for the Kessler study.
Every year, stroke affects nearly 800,000 people in the US, according to the Centers for Disease Control and Prevention. "Given the broad impact that stroke has on individuals, families, and caregivers, as well as health care services and our economy, the benefits of improving the outcomes for stroke rehabilitation are substantial," noted Steven Kirshblum, MD, chief medical officer for Kessler Foundation and Kessler Institute for Rehabilitation. Dr. Kirshblum also serves as chair of the Department of Physical Medicine and Rehabilitation at Rutgers New Jersey Medical School.
"Too often stroke results in long-term disability that adversely affects quality of life," Dr. Kirshblum continued. "Now we know that with early and intensive intervention, stroke survivors have the capability to regain function. The EMAGINE trial capitalizes on this neuroplasticity of the brain and spinal cord by augmenting standard rehabilitation with electromagnetic stimulation and making therapy available in different settings, including the home," he explained.
Each site plans to enroll individuals within four to 21 days of moderate-to-severe ischemic stroke. At Kessler, three participants to date have been enrolled in the study, which is randomized, sham-controlled, and double-blinded, according to Dr. Androwis, senior research scientist in the Center for Mobility and Rehabilitation Engineering Research at Kessler Foundation and director of the Center's Rehabilitation Robotics and Research Laboratory.
The first participant has completed the nine-week protocol, which comprises 45 one-hour sessions administered five times a week. During each session, the participant performs therapeutic exercises while wearing the device, which fits over their head and torso without interrupting the participant's ability to perform functional tasks with their upper extremities.
"Given the promising results of our already completed BrainQ trial in persons with chronic spinal cord injury, we are excited to study the potential benefits of this non-invasive brain and spine stimulation intervention in persons disabled by stroke," said Dr. Androwis.
Using machine learning, the BQ device targets affected areas of the brain with electromagnetic field therapy. The therapy, which is low intensity and frequency tuned, is administered along with the current standard for physical and occupational therapy, toward the goal of facilitating neurorecovery. Preliminary findings were promising, which prompted the FDA to award Breakthrough Device Designation to BrainQ's device in 2021.
BrainQ' s developers see the device's potential for a flexible continuum of therapy, from acute care, through rehabilitation and after discharge for at-home use. "Being able to stay engaged in therapy throughout the recovery process is a unique aspect of the EMAGINE study,"
Dr. Androwis emphasized. "Participants can access this investigational therapy from home, with oversight by a trained caregiver and remote monitoring by a member of the study team."
We are pleased that true leaders in rehabilitative research and clinical care, including Kessler Foundation and Kessler Institute, are our partners in the EMAGINE trial. Together, we are striving toward our common goal – to transform the future of stroke rehabilitation by restoring lost mobility through innovative technology applied to home-based solutions."
Yotam Drechsler, CEO of BrainQ
Eligible participants are recruited from Kessler Institute for Rehabilitation, a Select Medical inpatient rehabilitation hospital that provides rehabilitative care for stroke and other disabling conditions. In-patients undergoing stroke rehabilitation are evaluated for their eligibility by the Kessler study team.
The study is funded by BrainQ, developer of the investigational device.
Exploring the current use and future of alternatives to traditional informed consent in acute stroke trials