United States

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.

Thirty-eight typically developing children aged 8 to 12 used a design application to build their own picture-based interface for a P300 brain-computer interface augmentative and alternative communication (P300-BCI-AAC) system, in a study of what children themselves want from such interfaces. They consistently chose preferred colors, animation — zooming most of all — and sound cues: animation aided visual accessibility and target location, background color changes carried preferred colors into the display, and video GIFs and picture overlays added personal relevance. The authors call motion, color, personalization and visual clarity preliminary priorities for pediatric BCI-AAC design, and point to follow-up work with children who use AAC daily and with people who have motor difficulties.

Carnegie Mellon University researchers built an intracortical brain-computer interface that lets animals use visual neurofeedback to hold prefrontal cortex population activity near a preset target. Arousal drifts during tasks, with low arousal linked to drowsiness and high arousal to stress, and these departures from optimal performance show up as fluctuations in neural activity. With moment-by-moment feedback, the animals reduced those fluctuations on timescales from seconds down to hundreds of milliseconds, and arousal-related regulation of neural activity was associated with BCI use. The team says neurofeedback could help strengthen or restore regulation of neural activity in clinical conditions where arousal control is impaired. The work is a preprint, has not been peer reviewed and has been done only in animals.

A review published on August 20, 2026 in npj Biomedical Innovations proposes brain-inspired brain-computer interfaces (BI-BCIs), a framework that unifies neuromorphic computing with BCI design to make neurotechnology lower-power, smaller and capable of closed-loop operation. The authors, from Aarhus University, Stanford University, the University of Southern Denmark, the University of Genoa, Forschungszentrum Jülich and RWTH Aachen University, say the approach could advance neuroprosthetics and neuromodulation for neurological disorders.

A Stanford program is recording brain activity in psychiatric inpatients at millisecond precision, combining noninvasive electrode arrays with deep brain recording electrodes to trace the circuits behind schizoaffective disorder, borderline personality disorder, autism and cancer-induced depression. The Human Neural Circuitry program, led by neuroscientist Karl Deisseroth at the Wu Tsai Neurosciences Institute, has run for three years and moves data over fiber-optic and copper links fast enough for round trips of under half a millisecond, allowing the system to sense and respond in a closed loop. Deisseroth said the key innovation is getting results at millisecond precision, which he called a crucial step toward understanding complex psychiatric symptoms.

The Orion visual neuroprosthetic system, originally developed by Second Sight Medical Products, is changing parent companies again, Neurotech Reports said. Vivani Medical has agreed a reverse merger with Nasdaq-listed ClearOne under which its Cortigent unit becomes a wholly owned ClearOne subsidiary; ClearOne will be renamed Cortigent Holdings Inc. and is expected to trade as CRGT. ClearOne agreed as part of the transaction to file a Form S-1 registration statement to raise $10 million to $15 million, and Cortigent plans a pivotal trial of Orion in about 60 patients, though funding remains a challenge.

A paper in *Neurorehabilitation and Neural Repair* examines the outcome measures needed as implantable motor BCIs move from safety and feasibility studies toward regulatory approval, reimbursement and sustained clinical use. It calls for valid and reliable assessments that satisfy regulators and payers while reflecting activities that matter to people with severe motor impairment.

The US Food and Drug Administration cleared CN-Suite, source localization software from FIND Surgical Sciences Inc., doing business as FIND Neuro, on August 16, 2026, finding it substantially equivalent under submission number K260563 via the Traditional 510(k) pathway. FDA lists the device as Source Localization Software for Electroencephalograph or Magnetoencephalograph, a Class II device under regulation number 882.1400, reviewed by the agency's neurology advisory committee. Such software works back from electrical or magnetic fields recorded at the scalp to the intracranial origin of the signal, supporting presurgical planning such as locating epileptic foci.

SpikeGadgets says its hardware, using low-latency Ethernet and the TrodesNetwork API, lets researchers detect a neural activity pattern and trigger a perturbation within milliseconds. Two UCSF studies show it in use: one continuously decoded hippocampal population activity in rats to run a neurofeedback system, training the animals to volitionally generate specific memory representations for reward; the other triggered theta-phase-specific optogenetic stimulation in real time and showed that theta rhythm and replay are mechanistically separable.

Intracortical recordings from 3 BrainGate2 participants show preparatory motor cortex activity encodes movement direction, curvature, and distance, enabling preparatory-activity-based online cursor control.

A University of Pittsburgh team (Bose et al.) tested the crossmodal congruency effect (CCE) task in 15 able-bodied volunteers to see whether it can quantify how intuitive lower-limb sensory feedback feels. At the knee, the task distinguished more natural pneumatic stimulation from less natural electrical stimulation; at the foot, it could not tell the same stimuli apart. The study was posted to bioRxiv on August 10, 2026. Lower-limb amputees often have balance and gait problems because their prostheses give no somatosensory feedback; electrical-stimulation neuroprostheses can partly restore sensation, but there has been no way to quantify how intuitive that sensation is. The authors stress that external factors affecting the CCE must be identified before it can be used with amputees.

Baylor College of Medicine researchers analyzed more than 200 hours of intracranial recordings from eight patients with treatment-resistant obsessive-compulsive disorder, five of whom also had bilateral orbitofrontal ECoG electrodes. Neural signals alone did not decode symptom severity or momentary distress above chance; adding facial and speech features raised performance to R=0.73 for severity and R=0.34 for distress. The medRxiv preprint has not been peer reviewed.

The FDA has cleared Precision Neuroscience's Layer 7 Cortical Interface to stay implanted for up to 30 days, up from a previous 510(k) limit of 30 minutes of intraoperative use. The longer window opens the door to extended clinical studies and marks an intermediate step toward a permanent implant.

Researchers released a multi-paradigm longitudinal EEG dataset from 24 stroke patients, covering a novel 'sixth-finger' motor imagery paradigm and affected-hand motor imagery. The dataset spans the full pre-training, post-training and follow-up stages and includes raw EEG, preprocessed data and patient clinical information. Preliminary analysis with classical classifiers (CSP+SVM, CSP+LDA) kept average cross-paradigm classification accuracy at roughly 85%–86%.

Researchers evaluated the technical feasibility of a multimodal imaging workflow for deploying Synchron's Stentrode endovascular brain-computer interface in a human head phantom. The workflow — thin-slice CT, transfer of DICOM data to an external core laboratory for target identification and marking, re-import of the marked CT, 3D rotational angiography, and registration with the marked reconstruction and intraoperative fluoroscopy — produced a dataset suitable for anatomical analysis, with the core laboratory marking the intended deployment region and the markings persisting through transfer and re-import, and the annotated CT fusing with 3D angiography without significant misregistration or artifacts. The authors say the workflow can generate intraprocedural targeting guidance for Stentrode deployment, as a preclinical technical validation.

Researchers at the University of Michigan, Ann Arbor have built SpikeCleaner, an algorithm that grades neural units after automated spike sorting, reaching 97% accuracy and a 92% F1 score on single units in benchmarking. It combines spike rate, spike-timing metrics and waveform features to classify units as good, noise or multi-unit activity, a job that otherwise falls to manual curation.

US researchers using intracortical microelectrode arrays identified distinct neural patterns in the motor and somatosensory cortex of patients with spinal cord injury that separately encode the timing and force of grasping, offering new ideas for developing more precise brain-computer interface (BCI) systems.

The Center for Neurotechnology listed nine new papers spanning experimental and computational neuroscience, neural interfaces and neuroethics. The selection includes Smart Dura for multimodal neural recording and modulation, work on transcutaneous spinal-stimulation trials, primate optogenetics, co-adaptive interfaces, motor-cortex activity and participatory neuroethics research.

Researchers at the University of Washington have built mechanically compliant, precision-porous brain implants and tested them in rat brains. At 4 weeks, the porous scaffolds drew less astrocyte encapsulation than solid hydrogel rods, softer hydrogels reduced pro-inflammatory macrophage polarization, and new blood vessels, neuronal markers and neurogenesis appeared inside the pores. The authors present the design as a route to limiting glial scarring and improving regeneration in implant-based central nervous system therapies.

Brown University researchers have posted a preprint proposing Neural SS-DMP, a movement decoder that does not output hand coordinates directly: it first infers a compact set of parameters describing the motion the user intends, then hands them to a generator governed by physical dynamics that draws the full trajectory, so decoded output stays within motion a body can actually produce. The generator is tuned per person, blending general movement dynamics with the individual's own patterns estimated from training data, and the authors say that across two kinds of neural recording the model came out ahead of strong existing methods on both accuracy and trajectory smoothness while holding performance longer on recordings made after training ended. The study is a preprint, has not been peer reviewed, and its results come entirely from offline data rather than live control.

The VA Office of Research and Development is advancing a high-performance implanted brain-computer interface (BCI) to improve independence for Veterans and others with tetraplegia or inability to speak due to ALS, spinal cord injury, or stroke. The project enhances deep learning decoders and multi-state gesture decoding, deployed on a battery-powered mobile BCI device for independent home use of computers and touch-enabled devices. Accuracy and usability will be evaluated in participants already enrolled in the BrainGate investigational clinical trial.

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.

UC Davis researchers trained a transformer-based speech decoder across six people with intracortical BCIs. The pooled model cut relative word error rates by more than 50% on average compared with subject-only models and, after fine-tuning on fewer than 200 sentences from an unseen user, achieved a word error rate below 7%. The bioRxiv preprint has not been peer reviewed.