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.
Gaze stabilization and postural control are two key functions of the vestibular system. In consequence, oscillopsia and chronic imbalance are the two main complaints of patients presenting with a severe bilateral vestibular function loss. The vestibular implant is emerging as a promising treatment for this group of patients whose quality of life is significantly impaired. Although the final aim of the vestibular implant should be to restore vestibular function as a whole, until now the research has focused mainly on the restoration of the vestibulo-ocular reflex to improve gaze stabilization. In this study, we aimed to explore whether the vestibulo-collic and vestibulo-spinal pathways could be activated and controlled with the electrical stimuli provided by our vestibular implant prototype. This was first explored and demonstrated with recordings of electrically elicited cervical vestibular evoked myogenic potentials (ecVEMPs). ecVEMPs with characteristics similar to the classical acoustically elicited cervical vestibular evoked myogenic potentials (cVEMPs) were successfully evoked in five out of the eight tested patients. Amplitudes of the electrically elicited N–P complex varied, ranging from 44 to 120 µV. Mean latencies of the N and P waves were of 9.71(± 1.17) ms and 17.24 ms (± 1.74), respectively. We also evaluated the possibility of generating controlled postural responses using a stepping test. Here, we showed that controlled and consistent whole-body postural responses can be effectively obtained with rapid changes in the “baseline” (constant rate and amplitude) electrical activity delivered by the vestibular implant in two out of the three tested subjects. Furthermore, obtained amplitude of body rotations was significantly correlated with the intensity of stimulation and direction of body rotations correlated with the side of the delivered stimulus (implanted side). Altogether, these data suggest that the vestibular implant could also be used to improve postural control in patients with bilateral vestibulopathy.
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