JERUSALEM, March 11, 2021 /PRNewswire/ — BrainQ, the Israeli start-up with an AI-powered therapeutic platform, today revealed the encouraging results of their Randomized Controlled Trial (RCT) which supported a recently granted request for FDA Breakthrough Device Designation. The pilot trial data will be presented as part of the International Stroke Conference between March 17-19.
In a single site, the 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.
“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…