Researchers from the Kessler Foundation and the Kessler Institute for Rehabilitation (collectively “Kessler”) are enrolling participants in a national trial of an innovative device to enhance recovery after stroke. Kessler’s West Orange and Saddle Brook, NJ locations are among 20 US sites participating in the EMAGINE Stroke Recovery Trial, which combines therapeutic exercise with brain stimulation via a wearable device in research. Steven Kirshblum, MD, is the principal investigator and Ghaith Androwis, PhD is co-principal investigator of the Kessler study.
Each year, stroke affects nearly 800,000 people in the US, according to the Centers for Disease Control and Prevention. “Given the broad impact stroke has on individuals, families and caregivers, as well as on healthcare services and our economy, the benefits of improving stroke rehabilitation outcomes are substantial,” he said. Steven Kirshblum, MD, Kessler’s chief medical officer. Kessler Foundation and Institute for Rehabilitation. Dr. Kirshblum also serves as Chairman of the Department of Physical Medicine and Rehabilitation at Rutgers New Jersey Medical School.
“Too often, strokes cause long-term disability that negatively affects quality of life,” Dr. Kirshblum continued. “We now know that with early and intensive intervention, stroke survivors have the ability to regain function. The EMAGINE trial takes advantage of this neuroplasticity of the brain and spinal cord by augmenting standard rehabilitation with electromagnetic stimulation and making therapy be available in different environments, including the home,” he explained.
Each site plans to enroll people within 4 to 21 days of moderate to severe ischemic stroke. At Kessler, to date, three participants have been enrolled in the study, which is randomized, sham-controlled, and double-blind, according to Dr. Androwis, a senior research scientist at the Kessler Foundation’s Mobility and Rehabilitation Engineering Research Center. and director of the Center’s Rehabilitation Research and Robotics Laboratory.
The first participant has completed the nine-week protocol, which comprises 45 one-hour sessions administered five times per week. During each session, the participant performs therapeutic exercises while wearing the device, which is positioned over the head and torso without disrupting the participant’s ability to perform functional tasks with the upper extremities.
“Given the promising results of our completed BrainQ trial in people with chronic spinal cord injury, we are excited to study the potential benefits of this non-invasive brain and spinal stimulation intervention in people disabled by stroke,” he 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 tuned frequency, is administered in conjunction with current standard physical and occupational therapy, with the goal of facilitating neurological recovery. The preliminary findings were promising, leading the FDA to grant Breakthrough Device designation to the BrainQ device in 2021.
BrainQ developers see the device’s potential for flexible continuum therapy, from acute care through rehabilitation and post-discharge for use at home. “Being able to continue to participate in therapy throughout the recovery process is a unique aspect of the EMAGINE study,”
Dr. Andrewis emphasized. “Participants can access this investigational therapy from home, with supervision by a trained caregiver and remote control by a member of the study team.”
We are pleased that the true leaders in rehabilitation research and clinical care, including the Kessler Foundation and the Kessler Institute, are our partners in the EMAGINE trial. Together, we strive to achieve our common goal: to transform the future of stroke rehabilitation by restoring lost mobility through innovative technology applied to at-home solutions.”
Yotam Drechsler, CEO of BrainQ
Eligible participants are recruited from the Kessler Institute for Rehabilitation, a Select Medical inpatient rehabilitation hospital that provides rehabilitative care for stroke and other disabling conditions. Kessler’s study team assesses the eligibility of hospitalized patients undergoing stroke rehabilitation.
The study is funded by BrainQ, developer of the research device.