A Translational Platform for Brain-Computer Interfaces and Adaptive Neuromodulation: Technical Characterization, Long-Term Validation, and Implementation of the CorTec Brain Interchange--BCI2000 Ecosystem

Abstract

Objective: Adaptive neuromodulation systems and implantable brain-computer interfaces (BCIs) are promising therapies for neurological and psychiatric disorders. However, their broader translation into research and clinical practice remains limited by technological complexity, restricted access to implantable research platforms, and the lack of standardized, reproducible experimental workflows. We therefore aimed to develop and validate an open, general-purpose translational ecosystem that enables rapid development, evaluation, and dissemination of novel neuromodulation and implantable BCI paradigms. Approach: The CorTec Brain Interchange (BIC) implantable neural sensing and stimulation device was integrated with the open-source BCI2000 platform to create a modular, extensible neuromodulation ecosystem. We established a standardized battery of quantitative assessments to characterize implantable neuromodulation systems to comprehensively evaluate the CorTec BIC device through benchtop characterization, long-term preclinical in vitro and in vivo validation, and a human proof-of-concept demonstration. Results: Benchtop and saline testing provided a comprehensive technical ex vivo characterization of the BIC device, independently validating previously reported performance while extending its characterization through quantification of the recording noise floor, stimulation and acquisition latencies and impedance measurement accuracy. Long-term in vivo validation in five canines, with the longest implantation exceeding three years, demonstrated stable chronic recordings while capturing progressive channel deterioration and its underlying mechanical causes. The ecosystem enabled active functional decoding more than two years after implantation, implementation of closed-loop stimulation using arbitrary spectral biomarkers, detection and modulation of epilepsy-associated biomarkers, and brain stimulation evoked potential recordings. In addition, we translated an established one-dimensional BCI cursor control paradigm to the BIC benchtop evaluation kit and demonstrated its feasibility in a human participant. Finally, we openly provide standardized surgical, imaging, and analysis pipelines together with datasets and software to facilitate reproducible neuromodulation research. Significance: We present a versatile, open-source translational ecosystem that supports a wide range of neuromodulation and implantable BCI applications with minimal modification. This battery of quantitative assessments can be applied generally as a blueprint for systematic characterization of implantable neuromodulation systems. By combining comprehensive hardware characterization with standardized software tools and experimental workflows, this work provides both an essential reference for researchers adopting the Brain Interchange platform. The ecosystem lowers technical barriers to implantable neurotechnology research, promotes reproducibility, and provides a foundation for accelerating the development and clinical translation of next-generation adaptive neuromodulation and implantable BCI therapies for patients with neurological and psychiatric disorders.