Clinical Trial Wearable Transcranial Neurostimulation Show Reduction Disability After Stroke 

In a study of a wearable transcranial neurostimulation device (BrainQ, Jerusalm, Israel), 77% of participants in the treatment group in the study recovered to a level of no symptoms or no significant disability after stroke on the modified Rankin Scale (mRS). The study’s results supported the recently granted request for a Food & Drug Administration (FDA) Breakthrough Device Designation. 

The study was a double-blind randomized controlled trial with 25 enrolled participants. After 8 weeks of treatment, 77% of participants receiving neurostimulation had scores of 1 or 0 on the mRS. These scores meant the participants experienced either no symptoms or minor symptoms, and with no significant disability. Of the participants in the sham (control) group, 25% scored 1 or less. Also, 92% of the participants in the treatment group improved by 2 or more mRS points. The treated participants mRS mean scores improved by 2.5 points over the course of the study, compared with 1.3 points in the sham group. 

In the study, the Fugl-Meyer Assessment for upper extremity (FMA-UE) scores were significantly higher in the treatment group at week 4 (23.2±3.91 vs 9.9±3.2). The scores remained higher after 8 weeks of treatment (31.5±2.97 vs. 23.1±4.99) as well. At week 9 the for mRS treatment group showed a significantly greater decrease in disability than the controlled group (2.5±0.18 vs. 1.3±0.16). No adverse events were reported.

"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% to 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." 

"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," said Yotam Drechsler, chief executive officer and cofounder of BrainQ. "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."