BrainQ, an Israeli start-up, revealed encouraging results of their randomized controlled trial, which supported a recently granted request for FDA Breakthrough device designation.
The new study, to be presented at the International Stroke Conference on March 17th, shows that 77% of subjects receiving the BrainQ non-invasive therapy showed dramatic improvements. Essentially these subjects undergoing BrainQ therapy had either no symptoms or minor symptoms with no significant disability.
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These pilot results are striking, as BrainQ’s therapy suggests a beneficial effect in the subacute phase”, said Dr. Jeffrey Saver, director of the UCLA Comprehensive Stroke and Vascular Neurology Program and a lead Principal Investigator for BrainQ’s upcoming Pivotal Trial. “The current leading interventions for stroke are effective only in the few hours post-stroke and applicable to less than 5-10% of patients. This technology may have the ability to extend the time period in which corrective therapy can be delivered from hours to days and even weeks, and apply to a much larger patient population.”
BrainQ’s therapy uses machine learning algorithms to extract biological insights from brainwaves, which are used to imitate neural network synchronization’s natural processes.
The therapy is delivered to a patient via a cloud-connected wearable that transmits frequency-tuned low-intensity electromagnetic fields, facilitating neuroplasticity processes within the central nervous system.
In the case of stroke and other neurological disorders, the EMF (electromagnetic fields) oscillatory patterns of unhealthy or impaired individuals are measurably different from those of healthy individuals.
BrainQ ’s treatment targets specific networks in the central nervous system, utilizing an extremely-low-frequency and low-intensity electromagnetic field (ELF-EMF) treatment tuned to specific frequencies to repair damaged neural networks.
The start-up is developing breakthrough precision neurology therapies using Brain-Computer Interface technology, an emerging digital therapeutics field.