Researchers from the Kessler Foundation and the Kessler Institute for Rehabilitation (collectively “Kessler”) are enrolling participants in a nationwide trial of a breakthrough device to improve recovery after stroke. Kessler sites in West Orange and Saddle Brook, NJ, are among 20 sites across the United States participating in the EMAGINE Stroke Recovery trial, which combines therapeutic exercise with brain stimulation through an experimental wearable device . Steven Kirshblum, MD, is the principal investigator and Ghaith Androwis, PhD, is the co-principal investigator of the Kessler study.
Each year, strokes affect nearly 800,000 people in the United States, according to the Centers for Disease Control and Prevention. “Given the general impact of stroke on individuals, families and caregivers, as well as on health services and our economy, the benefits of improving stroke rehabilitation outcomes are substantial” noted Steven Kirshblum, MD, chief medical officer of the Kessler Foundation and Kessler Institute for Rehabilitation. Dr. Kirshblum is also chairman of the Department of Physical Medicine and Rehabilitation at Rutgers New Jersey Medical School.
“Too often, stroke results in 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 capitalizes on this neuroplasticity of the brain and spinal cord by augmenting standard rehabilitation with stimulation electromagnetic therapy and making the therapy available in different settings, including the home,” he explained.
Each site plans to enroll people 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, simulation-controlled and double-blind, according to Dr. Androwis, principal investigator at the Mobility and Rehabilitation Engineering Research Center of the Kessler Foundation and director of the Center’s Robotics and Rehabilitation Research Laboratory.
The first participant completed the nine-week protocol, which includes 45 one-hour sessions administered five times per 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 limbs.
“Given the promising results of our already completed BrainQ trial in people with chronic spinal cord injury, we are excited to investigate the potential benefits of this non-invasive brain and spine stimulation intervention in people 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 regulated frequency, is administered with the current standard of physiotherapy and occupational therapy, with the aim of facilitating neurological recovery. Preliminary findings were promising, prompting the FDA to award Breakthrough Device designation to BrainQ’s device in 2021.
BrainQ’s developers see the device’s potential for a flexible therapy continuum, from acute care to rehabilitation and post-discharge for home use. “Being able to stay engaged in therapy throughout the recovery process is a unique aspect of the EMAGINE study,”
pointed out Dr. Androwis. “Participants can access this experimental therapy from home, under the supervision of a trained caregiver and remote monitoring by a member of the study team.”
We are delighted to have true leaders in rehabilitation research and clinical care, including the Kessler Foundation and the Kessler Institute, as our partners in the EMAGINE trial. Together, we are striving to achieve our common goal: to transform the future of stroke rehabilitation by restoring lost mobility through innovative technology applied to 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. The Kessler study team assesses the eligibility of patients hospitalized for stroke rehabilitation.
The study is funded by BrainQ, developer of the experimental device.
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