BrainQ, an Israeli start-up with an artificial intelligence- (AI) powered therapeutic platform, has announced the results from a randomised controlled trial (RCT), showing 77% of treatment group recovered to a level of no symptoms or no significant disability on the modified Rankin Scale (mRS).
BrainQ claims that the study is a single-site, double-blinded RCT including 25 subjects. The company reports that 77% of the subjects receiving the BrainQ therapy had scores of one or zero on the mRS. 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.
According to 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. Additionally, the company reported no related adverse events were recorded.
“These pilot results are striking, as BrainQ’s therapy suggests a beneficial effect in the subacute phase”, said Jeffrey Saver, director of the UCLA Comprehensive Stroke and Vascular Neurology Program, and a lead principal investigator for BrainQ’s upcoming pivotal trial, Los Angeles, USA. “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.”
Saver continued: “With 800,000 strokes each year in the US alone, this therapy has the potential to greatly advance stroke care. I am eager to see the next phase of clinical trials.”
BrainQ state its therapy uses machine learning algorithms to extract biological insights from brainwaves, which are used to imitate the natural processes of neural network synchronisation. 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.
“These promising results indicate that we are on the path to bringing hope to ischemic stroke patients with limited options after acute care ends with our novel technology,” said Yotam Drechsler, CEO and co-founder of BrainQ. “As we are 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.”