RESUMO
This article deals with the long-term preclinical validation of WIMAGINE® (Wireless Implantable Multi-channel Acquisition system for Generic Interface with Neurons), a 64-channel wireless implantable recorder that measures the electrical activity at the cortical surface (electrocorticography, ECoG). The WIMAGINE® implant was designed for chronic wireless neuronal signal acquisition, to be used e.g., as an intracranial Brain-Computer Interface (BCI) for severely motor-impaired patients. Due to the size and shape of WIMAGINE®, sheep appeared to be the best animal model on which to carry out long-term in vivo validation. The devices were implanted in two sheep for a follow-up period of 10 months, including idle state cortical recordings and Somato-Sensory Evoked Potential (SSEP) sessions. ECoG and SSEP demonstrated relatively stable behavior during the 10-month observation period. Information recorded from the SensoriMotor Cortex (SMC) showed an SSEP phase reversal, indicating the cortical site of the sensorimotor activity was retained after 10 months of contact. Based on weekly recordings of raw ECoG signals, the effective bandwidth was in the range of 230 Hz for both animals and remarkably stable over time, meaning preservation of the high frequency bands valuable for decoding of the brain activity using BCIs. The power spectral density (in dB/Hz), on a log scale, was of the order of 2.2, -4.5 and -18 for the frequency bands (10-40), (40-100), and (100-200) Hz, respectively. The outcome of this preclinical work is the first long-term in vivo validation of the WIMAGINE® implant, highlighting its ability to record the brain electrical activity through the dura mater and to send wireless digitized data to the external base station. Apart from local adhesion of the dura to the skull, the neurosurgeon did not face any difficulty in the implantation of the WIMAGINE® device and post-mortem analysis of the brain revealed no side effect related to the implantation. We also report on the reliability of the system; including the implantable device, the antennas module and the external base station.
RESUMO
An in vivo setup for pulsed electric field exposure at 3 GHz is proposed and characterized in this work. The exposure system allows far field, whole-body exposure of six animals placed in Plexiglas cages with a circular antenna. Chronic exposures under 18 W incident average power (1-4 kW peak power) and acute exposures under 56 W incident average power (4.7 kW peak power) were considered. Numerical and experimental dosimetry of the setup allowed the accurate calculation of specific absorption rate (SAR) distributions under various exposure conditions. From rat model numerical simulations, the whole-body mean SAR values were 1.3 W kg(-1) under chronic exposures and 4.1 W kg(-1) under acute exposure. The brain-averaged SAR value was 1.8 W kg(-1) and 5.7 W kg(-1) under chronic and acute exposure, respectively. Under acute exposure conditions, a 10 g specific absorption of 1.8 ± 1.1 mJ · kg(-1) value was obtained. With temperature rises below 0.8 °C, as measured or simulated on a gel phantom under typical in vivo exposures, this exposure system provides adequate conditions for in vivo experimental investigations under non-thermal conditions.