ABSTRACT
Objective: To explore maternal humoral immune responses to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection and the rate of vertical transmission. Study Design: A prospective cohort study was conducted at two university-affiliated medical centers. Women positive for SARS-CoV-2, as determined by reverse-transcription-polymerase-chain-reaction (RT-PCR), during pregnancy were enrolled just prior to delivery. Levels of anti-SARS-CoV-2 nucleocapsid IgG, spike IgG and spike-IgM were tested in maternal and cord blood at delivery, and neonatal nasopharyngeal swabs were subjected to PCR testing. The primary endpoint was the rate of vertical transmission, defined as either positive neonatal IgM, positive neonatal IgG with sero-negative mother or positive neonatal PCR. The rate of vertical transmission was estimated to be 7% when defined by RT-PCR. Assuming that using serology tests increases the rate to 10% versus 0% in non-infected population, 71 women were required (80% power, 5% one-sided alpha) Results: Among 72 women, 36 (50%), 39 (54%) and 30 (42%) were positive for anti-spike-IgM, anti-spike-IgG and anti-nucleocapsid-IgG, respectively (p < 0.0001 for IgG antibodies;table). At least 8/72 (11%) neonates were infected in utero;one had a positive PCR and seven had positive IgG while their mothers were seronegative for the same IgG. IgM was not detected in cord blood. Anti-nucleocapsid-IgG and anti-spike-IgG were detected in 83% and 85% of neonates of seropositive mothers, respectively (Pearson coefficient correlation 0.8, p< 0.001). The highest rate of positive maternal serology tests was 8-12 weeks post-infection (89% anti-spike IgG, 78% anti-spike IgM and 67% anti-nucleocapsid IgG). Thereafter, the rate of positive serology tests declined gradually;at 20 weeks post-infection, only anti-spike IgG was detected in 33-50% (figure). Conclusion: The rate of vertical transmission was at least 11%. Vaccination should be considered 3 months post-infection in pregnant women due to a decline in antibody levels. [Formula presented] [Formula presented]
ABSTRACT
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
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 frequencytuned 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 alsoobserved 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, supportingthe safety of the treatment. Conclusion: Our results show that BQ treatment significantly improves UEMF in a sub-acuteischemic stroke population across multiple clinical metrics. Further studies are planned and ongoingwith larger study populations, and in related indications.