BrainQ has announced that the first patient has been enrolled at MedStar National Rehabilitation Hospital (Washington, USA) in the pivotal, randomised, double-blind, multicentre EMAGINE trial, which is evaluating its frequency-tuned electromagnetic field treatment in facilitating recovery in individuals with moderately severe ischaemic stroke.
The EMAGINE stroke recovery trial (the BQ5 study) provides a remote and decentralised care model, and will enrol 150 randomised subjects between four and 10 days following a stroke, with up to 19 academic sites expected to participate in the study. According to a BrainQ press release, the primary outcome measure for the EMAGINE trial is score on the modified Rankin Scale (mRS), the gold standard for measuring disability post-stroke.
The study is designed to allow for participants to receive the company’s BQ therapy—beginning during acute hospitalisation, and accompanying them to the inpatient rehab facility, and eventually home.
“Over the past two decades, we have made major advances in acute stroke treatment. But, still, 90% of stroke patients experience long-term disability,” said Jeffrey Saver, director of the University of California, Los Angeles (UCLA) Comprehensive Stroke and Vascular Neurology Program in Los Angeles, USA, and a co-lead principal investigator for BrainQ’s pivotal trial. “Advances in recovery are the next frontier for the stroke community. Success of this study would be a gamechanger 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, professor of Neurology at Wake Forest School of Medicine in Winston-Salem, USA, and a co-lead principal investigator of EMAGINE. “There is a potential that BrainQ’s therapy, coupled with exercise training commencing within a few days of stroke and continuing for nine weeks, will optimise recovery and reduce stroke disability.”
The EMAGINE trial includes 45 sessions over a total of nine weeks, taking place five times a week. Each session will last for 60 minutes. The BQ device—an investigational therapy—is operated remotely with the assistance of a caregiver in conjunction with periodic remote monitoring by a physical or occupational therapist, and is intended to be used adjunctively with the current standard of care, physical or occupational therapy.
The currently approved interventions for reducing disability after a stroke, including medical and surgical options, are treatment options in the first few hours post-stroke and are only accessible for about 5% of stroke patients in the USA, the release adds. BrainQ is aiming to extend this window of opportunity for reducing disability from the acute phase to the sub-acute phase, helping the wider stroke population.