Kessler partners with BrainQ on national trial of innovative approach to stroke rehabilitation
Multisite EMAGINE Stroke Recovery Trial tests breakthrough technology for stimulating the brain and spinal cord to enhance recovery of lost function
East Hanover, NJ. November 21, 2022. 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,” said Yotam Drechsler, CEO of BrainQ. “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.”
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.
For more information, visit the EMAGINE website.
BrainQ, the EMAGINE Stroke Recovery Trial sponsor, is a US and Israel-based company pioneering a novel therapy for reducing disability and maximizing the recovery potential for stroke and other disabling neurological conditions. Their investigational device received FDA Breakthrough Device Designation. Their mission is to restore independence for the millions of people with disability worldwide through home-based accessible solutions.
Worldwide, the BrainQ technology is limited to investigational use only and is not approved or available for sale. BrainQ makes no guarantees regarding clinical trial outcomes or regulatory approval for its technology.
About Kessler Foundation
Kessler Foundation, a major nonprofit organization in the field of disability, is a global leader in rehabilitation research that seeks to improve cognition, mobility, and long-term outcomes – including employment – for people with neurological disabilities caused by diseases and injuries of the brain and spinal cord. Kessler Foundation leads the nation in funding innovative programs that expand opportunities for employment for people with disabilities.
About Select Medical
Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on number of facilities. As of September 30, 2022, Select Medical operated 105 critical illness recovery hospitals in 28 states, 31 rehabilitation hospitals in 12 states, and 1,933 outpatient rehabilitation clinics in 39 states and the District of Columbia. Concentra operated 519 occupational health centers in 41 states. At September 30, 2022, Select Medical had operations in 46 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.