Israeli-based start-up BrainQ reveals encouraging results of the Randomized Controlled Trial (RCT) of its AI-powered therapeutic platform designed to help reduce disability after stroke.
The single-site, double-blind RCT included 25 subjects. After 8 weeks of treatment, 77% of the subjects receiving the BrainQ therapy had scores of 1 or 0 on the modified Rankin Scale (mRS), the gold standard for measuring disability following stroke. This translates to subjects having either no symptoms or minor symptoms, and with no significant disability. Only 25% of the subjects in the sham (control) group scored 1 or less. Additionally, 92% of subjects in the treatment group improved by 2 or more mRS points.
The BrainQ subjects’ mRS scores improved by an average of 2.5 points over the course of the study, compared with 1.3 points in the sham group. No related adverse events were recorded.
The study supports a recently granted request for FDA Breakthrough Device Designation. The pilot trial data will be presented as part of the International Stroke Conference, which will take place online March 17-19, BrainQ explains in a media release.
“These pilot results are striking, as BrainQ’s therapy suggests a beneficial effect in the subacute phase. 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 be applicable to a much larger patient population.”
“With 800,000 strokes each year in the US alone, this therapy has the potential to greatly advance stroke care. I’m eager to see the next phase of clinical trials.”
— Dr. Jeffrey Saver, Director of the UCLA Comprehensive Stroke and Vascular Neurology Program, and a lead Principal Investigator for BrainQ’s upcoming Pivotal Trial
BrainQ’s therapy uses machine learning algorithms to extract biological insights from brainwaves, which are used to imitate the natural processes of neural network synchronization. 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, per the release.
“These promising results indicate that we’re on the path to bringing hope to ischemic stroke patients with limited options after acute care ends with our novel technology. As we’re approaching a pivotal study with US sites, our goal is to bring our therapy to market and become the leading home-based neuro-therapeutics solution.”
— Yotam Drechsler, CEO and Co-founder of BrainQ
[Source(s): BrainQ, PR Newswire]