Case Western Reserve University

A workshop at the BCI Society Meeting 2025, run with the Implantable BCI Collaborative Community (iBCI-CC), took up how clinical outcome assessments (COAs) for pivotal BCI trials should be selected, developed and validated. Participants pointed to patient heterogeneity, the absence of widely validated COAs, and the difficulty of capturing outcomes that matter in home and daily-life settings. The discussion lays groundwork for the iBCI-CC Clinical Study Endpoints Workgroup to build a transparent process for identifying meaningful aspects of health and concepts of interest, in support of regulatory approval and reimbursement.

The study uses spatial proteomics to assess tissue around non-functional intracortical microelectrodes implanted for four weeks in mice, measuring neuronal integrity, immune-cell activation and local cytokine expression around probes coated with drug-loaded, controlled-release titanium dioxide nanotube array (TNA) coatings. The authors note that blood-brain barrier disruption can translocate gut-derived bacteria to the implant site and sustain chronic inflammation, and that the TNA coating's therapeutic loading and controlled release further damp residual neuroinflammation. They conclude that TNA offers a multifunctional, tunable interface for locally regulating the neuroimmune microenvironment, a step toward long-term reliable intracortical recordings.

Researchers evaluated ruthenium-oxide-coated amorphous silicon-carbide microelectrode arrays during 25 weeks of intracortical microstimulation in rodents. Perception thresholds stabilized at about 0.4 nC per phase per electrode by week nine, behavioral performance remained around 91%, and reliable sensation persisted through week 25.

Researchers transferred dexamethasone-loaded titania nanotube arrays (TNA) onto a mechanically adaptive polymer nanocomposite (NC) substrate and, in a mouse model, compared four implants — silicon, NC, TNA-NC Empty and TNA-NC DEX (10 mice per group) — for neuroinflammation around intracortical microelectrodes at 2 and 4 weeks. At 2 weeks the gene-expression profiles were broadly similar, reflecting an early acute injury response; by 4 weeks the patterns diverged, with NC-based implants showing fewer differentially expressed neuroinflammatory genes than rigid silicon, led by TNA-NC Empty, while the dexamethasone group showed no additional benefit, suggesting drug delivery still needs optimization. The authors conclude that adding a TNA layer to flexible materials promotes resolution of the neuroinflammatory response at 4 weeks.