By: BrainQ team
WASHINGTON, Dec. 9, 2021 – BrainQ today announced that the first patient has been enrolled at MedStar National Rehabilitation Hospital in its pivotal, randomized, double-blind, multicenter trial, EMAGINE (the BQ5 Study). The trial is evaluating its frequency-tuned electromagnetic field treatment in facilitating recovery in individuals with moderately-severe ischemic stroke.
The EMAGINE Stroke Recovery Trial provides a remote and decentralized care model and will enroll 150 randomized subjects 4-10 days following a stroke. The study is designed to allow for participants to receive the BQ therapy beginning during the acute hospitalization, and accompanying them to the inpatient rehab facility, and eventually home. The BQ device is operated remotely with the assistance of a caregiver in conjunction with periodic remote monitoring by a physical or occupational therapist.
The trial includes 45 sessions over a total of 9 weeks, 5 times a week. Each session will last for 60 minutes. The investigational therapy is intended to be used adjunctively with the current standard of care, physical or occupational therapy.
The primary outcome measure for the EMAGINE Trial is the modified Rankin Scale (mRS), the gold standard for measuring global disability post-stroke. The currently-approved interventions for reducing global disability after a stroke, including medical and surgical options, are treatment options only in the first few hours following a stroke and only for about 5% of stroke victims in the US. BrainQ aims to extend this window of opportunity for reducing disability from the acute phase to the sub-acute phase, helping the wider stroke population.
"With one in four adults expected to have a stroke in their lifetime, and few options on the market for reducing disability, this trial has the potential to make a significant impact on the ever-growing population of stroke survivors suffering from long term disability," said Yotam Drechsler, CEO and Co-founder of BrainQ. "Recruiting the first patient is just the first step to unlocking new opportunities for survivors and helping to meet this huge unmet need. We hope to continue strong recruitment for our trial over the next year."
"Over the past two decades, we have made major advances in acute stroke treatment. But still 90% of stroke patients experience long-term disability. Advances in recovery are the next frontier for the stroke community," said Dr. Jeffrey Saver, Director of the UCLA Comprehensive Stroke and Vascular Neurology Program, and a co-lead Principal Investigator for BrainQ's pivotal trial. "Success of this study would be a game changer for stroke recovery and help pave the way for a new standard of care for stroke."
"For many years, stroke rehabilitation has lacked novel technologies that change the treatment paradigm for patients," added Pamela Duncan PhD, PT, Professor of Neurology at Wake Forest School of Medicine and a co-lead Principal Investigator of BrainQ's pivotal trial. "There is a potential that BrainQ's therapy coupled with exercise training commencing within a few days of stroke and continuing for 9 weeks will optimize recovery and reduce stroke disability.
Up to 19 top academic sites will participate in the study. For more information about the trial and participating sites, please visit clinicaltrials.gov.
BrainQ is pioneering a novel therapy for reducing disability and enhancing recovery potential for stroke victims at home. BrainQ's team and advisory board include a multidisciplinary group with vast backgrounds in neurology, neuroscience, data science and machine learning.
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.
Read the PR Newswire article here.