Novel and non-invasive brain-computer interface-based stimulation device using frequency tuned electromagnetic fields to significantly reduce disability following sub-acute ischemic stroke: A pilot randomized controlled trial

Background: Exposure of the central nervous system to extremely low frequency and low intensity electromagnetic fields (ELF-EMF) increases plasticity-related processes, with associated clinical improvements. Aim: The purpose of this RCT was to explore the benefit of BrainQ’s novel and non-invasive stimulation device which uses frequency-tuned ELF-EMF treatment (BQ) to reduce general disability and improve upper extremity motor function (UEMF) in subacute ischemic stroke. Methods: Study was planned for n=50, but was discontinued due to COVID-19 at n=25. Participants were randomized to receive 40 minutes of BQ (active or sham) 5 days/week, for 8 weeks, with 10 minutes of PT. BQ uses brain-computer interface-based machine learning algorithms to extract motor-related spectral features in EEG for use as treatment frequencies, and is delivered via a wearable and portable device. Results: Primary endpoint: Fugl-Meyer Assessment – Upper Extremity improved significantly (and sooner) in the treatment group versus sham at W4 (23.2±3.91 vs. 9.9±3.2;13.6 points greater than sham p=0.0070) and after 8 weeks of treatment (31.5±2.97 vs. 23.1±4.99;p=0.0611). Secondary endpoints: Most strikingly, and as a major clinical indication of reduced disability, mRS, at W9 the treatment group showed a mean improvement of 2.5±0.18 points versus 1.3±0.16 points in the sham group (p=0.0005), i.e., a mean of 1.2 points higher than that of the sham group. Significant improvements were also observed in the ARAT–Pinch subscale (W9: p=0.0082), BBT (W6: p=0.0169;W9: p<0.0001), and NIHSS (W9: p=0.0340). Conclusion: BQ treatment significantly reduces general disability and improves UEMF in subacute ischemic stroke across multiple metrics. A pivotal study is planned, with an explicit motivation of moving toward home use, for a more patient-centric approach. Keywords: Brain computer interface, Non-invasive brain stimulation, Neurological recovery, Stroke