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IntroductionBi-directional brain-computer interfaces (BD-BCI) to restore movement and sensation must achieve concurrent operation of recording and decoding of motor commands from the brain and stimulating the brain with somatosensory feedback.MethodsA custom programmable direct cortical stimulator (DCS) capable of eliciting artificial sensorimotor response was integrated into an embedded BCI system to form a safe, independent, wireless, and battery powered testbed to explore BD-BCI concepts at a low cost. The BD-BCI stimulator output was tested in phantom brain tissue by assessing its ability to deliver electrical stimulation equivalent to an FDA-approved commercial electrical cortical stimulator. Subsequently, the stimulator was tested in an epilepsy patient with subcortical electrocorticographic (ECoG) implants covering the sensorimotor cortex to assess its ability to elicit equivalent responses as the FDA-approved counterpart. Additional safety features (impedance monitoring, artifact mitigation, and passive and active charge balancing mechanisms) were also implemeneted and tested in phantom brain tissue. Finally, concurrent operation with interleaved stimulation and BCI decoding was tested in a phantom brain as a proof-of-concept operation of BD-BCI system.ResultsThe benchtop prototype BD-BCI stimulator's basic output features (current amplitude, pulse frequency, pulse width, train duration) were validated by demonstrating the output-equivalency to an FDA-approved commercial cortical electrical stimulator (R 2 > 0.99). Charge-neutral stimulation was demonstrated with pulse-width modulation-based correction algorithm preventing steady state voltage deviation. Artifact mitigation achieved a 64.5% peak voltage reduction. Highly accurate impedance monitoring was achieved with R 2 > 0.99 between measured and actual impedance, which in-turn enabled accurate charge density monitoring. An online BCI decoding accuracy of 93.2% between instructional cues and decoded states was achieved while delivering interleaved stimulation. The brain stimulation mapping via ECoG grids in an epilepsy patient showed that the two stimulators elicit equivalent responses.SignificanceThis study demonstrates clinical validation of a fully-programmable electrical stimulator, integrated into an embedded BCI system. This low-cost BD-BCI system is safe and readily applicable as a testbed for BD-BCI research. In particular, it provides an all-inclusive hardware platform that approximates the limitations in a near-future implantable BD-BCI. This successful benchtop/human validation of the programmable electrical stimulator in a BD-BCI system is a critical milestone toward fully-implantable BD-BCI systems.

This paper presents an ultra-low power mixed-signal neural data acquisition (MSN-DAQ) system that enables a novel low-power hybrid-domain neural decoding architecture for implantable brain-machine interfaces with high channel count. Implemented in 180nm CMOS technology, the 32-channel custom chip operates at 1V supply voltage and achieves excellent performance including 1.07µW/channel, 2.37/5.62 NEF/PEF and 88dB common-mode rejection ratio (CMRR) with significant back-end power-saving advantage compared to prior works. The fabricated prototype was further evaluated with in vivo human tests at bedside, and its performance closely follows that of a commercial recording system.

Fully-implantable, bi-directional brain-computer interfaces (BCIs) necessitate simultaneous cortical recording and stimulation. This is challenging since electrostimulation of cortical tissue typically causes strong artifacts that may saturate ultra-low power (ULP) analog front-ends of fully-implantable BCIs. To address this problem, we propose an efficient hardware-based method for artifact suppression that employs an auxiliary stimulator with polarity opposite to that of the primary stimulator. The feasibility of this method was explored first in simulations, and then experimentally with brain phantom tissue and electrocorticogram (ECoG) electrode grids. We find that the canceling stimulator can reduce stimulation artifacts below the saturation limit of a typical ULP front-end, while delivering only ~10% of the primary stimulator's voltage.

This work presents a bi-directional brain-computer interface (BD-BCI) including a high-dynamic-range (HDR) two-step time-domain neural acquisition (TTNA) system and a high-voltage (HV) multipolar neural stimulation system incorporating dual-mode time-based charge balancing (DTCB) technique. The proposed TTNA includes four independent recording modules that can sense microvolt neural signals while tolerating large stimulation artifacts. In addition, it exhibits an integrated input-referred noise of 2.3 μVrms from 0.1- to 250-Hz and can handle a linear input-signal swing of up to 340 mVPP. The multipolar stimulator is composed of four standalone stimulators each with a maximum current of up to 14 mA (±20-V of voltage compliance) and 8-bit resolution. An inter-channel interference cancellation circuitry is introduced to preserve the accuracy and effectiveness of the DTCB method in the multipolar-stimulation configuration. Fabricated in an HV 180-nm CMOS technology, the BD-BCI chipset undergoes extensive in-vitro and in-vivo evaluations. The recording system achieves a measured SNDR, SFDR, and CMRR of 84.8 dB, 89.6 dB, and >105 dB, respectively. The measurement results verify that the stimulation system is capable of performing high-precision charge balancing with ±2 mV and ±7.5 mV accuracy in the interpulse-bounded time-based charge balancing (TCB) and artifactless TCB modes, respectively.

This paper presents an ultra-low power mixed-signal neural data acquisition (MSN-DAQ) system that enables a novel low-power hybrid-domain neural decoding architecture for implantable brain-machine interfaces with high channel count. Implemented in 180nm CMOS technology, the 32-channel custom chip operates at 1V supply voltage and achieves excellent performance including 1.07µW/channel, 2.37/5.62 NEF/PEF and 88dB common-mode rejection ratio (CMRR) with significant back-end power-saving advantage compared to prior works. The fabricated prototype was further evaluated with in vivo human tests at bedside, and its performance closely follows that of a commercial recording system.