Non-invasive Stimulation Device Research Articles

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

Device and procedure to treat cardiac atrial arrhythmias

A non-invasive vagal stimulation device (10) comprises a body having a vibration member (14). The stimulation is created by the vibration member (14) which has a vibratory rate that can be adjusted from being off to a preferred operating range. The non-invasive stimulation method consists of placing the non-invasive stimulation device (10) in the vicinity of the carotid artery bifrication where arises a carotid sinus and body which contain afferent sensory nerves that travel to medulla oblongata of brain, and either applying pressure in place, or moving the device (10) along the target arm. The method can be accomplished either with the vibration feature of the device turned on or off.