Kellar, Douglas J

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 vivo validation, and a human feasibility demonstration using the benchtop BIC system connected to externalized leads.
Results: Comprehensive benchtop characterization of the BIC device independently validated previously reported performance while extending its evaluation through quantification of recording noise, acquisition and stimulation latencies, and validation of impedance measurements. Long-term in vivo validation in five canines, with the longest implantation exceeding three years, demonstrated stable chronic recordings while also capturing progressive deterioration of individual channels through longitudinal changes in signal quality and impedance. The ecosystem enabled active functional decoding more than two years after implantation, closed-loop stimulation using arbitrary spectral biomarkers, capturing brain stimulation evoked potentials, detection of epilepsy-associated biomarkers and observational assessment of their response to stimulation. In addition, we translated an established one-dimensional BCI cursor-control paradigm to the BIC benchtop system, demonstrating ecosystem portability and feasibility with a human participant. Finally, we share surgical protocols, imaging and analysis pipelines, 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. By combining comprehensive hardware characterization with standardized software tools and experimental workflows, this work provides a practical reference for researchers adopting the BIC platform while establishing a broadly applicable framework for systematic characterization of implantable neuromodulation systems. 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.