Abstract P194: Artificial Intelligence-Powered Non-Invasive and Frequency-Tuned Electromagnetic Field Therapy Improves Upper Extremity Motor Function in Sub-Acute Stroke Patients: A Pilot Randomized Controlled Trial

Abstract

Background: Neural oscillations at specific frequencies have been associated with increased neuroplasticity. Additionally, exposure to extremely low frequency and low intensity electromagnetic fields (ELF-EMF) increases plasticity-related processes, with associated clinical improvements. Aim: The purpose of this double-blind sham-controlled trial was to explore the benefit of BrainQ’s novel and non-invasive, artificial intelligence-powered, frequency-tuned ELF-EMF treatment (BQ) in improving upper extremity motor function (UEMF) in a sub-acute ischemic stroke population. Methods: Study was planned for 50 subjects, but was discontinued due to COVID-19 at 25 subjects. Participants were randomized to receive 40 minutes of BQ treatment (active or sham) 5 days/week, for 8 weeks, in conjunction with 10 minutes of physical therapy. The BQ treatment uses artificial intelligence-based algorithms to extract motor-related spectral features in EEG for use as treatment frequencies. BQ treatment is delivered via a wearable device that transmits frequency-tuned ELF-EMF, facilitating neuroplasticity processes within the central nervous system. Primary endpoint: Fugl-Meyer Assessment - Upper Extremity (FMA-UE); Secondary endpoints: mRS, Action Research Arm Test (ARAT), Box and Block Test (BBT), NIHSS. Results: FMA-UE scores improved significantly (and sooner) in the treatment group versus sham at week 4 (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). For mRS, at week 9 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 (week 9: p=0.0082), BBT (week 6: p=0.0169; week 9: p<0.0001), and NIHSS (week 9: p=0.0340). No related adverse events were reported, supporting the safety of the treatment. Conclusion: Our results show that BQ treatment significantly improves UEMF in a sub-acute ischemic stroke population across multiple clinical metrics. Further studies are planned and ongoing with larger study populations, and in related indications.