Abstract

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.

Highlights

  • Brain–Computer Interface (BCI) encompass various types of system, which have the common function of establishing a direct communication link between the brain and an external device

  • Surgery was successfully performed on two large animals and ECoG signals were recorded weekly for 10 months

  • Long-term SomatoSensory Evoked Potential (SSEP) and signal recordings were obtained using the WIMAGINE implant in an awake ovine model, using the acquisition platform developed for clinical trials;

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Summary

Introduction

Brain–Computer Interface (BCI) encompass various types of system, which have the common function of establishing a direct communication link between the brain and an external device. The large majority of these systems are non-invasive using a wearable cap to record brain activity from the scalp using either wet or dry Electroencephalography (EEG) electrodes. Among the BCI community, a large number of researchers are struggling to meet the needs of biofeedback-based applications and/or of clinical research, using non-invasive EEG recording systems with centimeter pitched contacts (Schwartz et al, 2006). These contacts record noisy signals generated by large cortical surfaces. These systems became popular due to the first chronically implanted

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