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Precision launches brain–computer interface studies at two sites

Precision Neuroscience has expanded clinical research in brain-computer interfaces by launching two new study sites at Mount Sinai Health System and Perelman School of Medicine at the University of Pennsylvania (Penn Medicine) in the US.

These studies are set to advance the understanding of brain-controlled movement and are integral to Precision’s mission to improve the lives of those with neurological disorders.

The research utilises Precision’s brain implant, the Layer 7 Cortical Interface, which is designed to record neural activity with unprecedented resolution.

The interface comprises 1,024 tiny electrodes spanning a 1.5cm² area, embedded in a flexible film that conforms to the brain’s surface.

Designed to be implanted and removed by neurosurgeons without damaging brain tissue, the film is one-fifth the thickness of a human hair.

Throughout an open-label, single-arm feasibility investigation, neurosurgeons at Mount Sinai temporarily place the device onto the surfaces of participants’ brains during intracranial procedures that routinely include surface mapping.

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These mappings are then correlated to evoked potentials (which gauge the brain’s reaction to sensory stimuli) or standardised behavioural tasks.

The device captures high-resolution electrophysiological signals, with the data collected subsequently compared to that obtained through standard-of-care cortical surface arrays.

The team is examining the potential of high-resolution cortical surface arrays in various clinical applications.

Penn Medicine’s study, under the guidance of Dr Iahn Cajigas Gonzales from the Perelman School of Medicine at the Hospital of the University of Pennsylvania, aims to decode neural signals that control hand movement.

Patients undergoing awake neurosurgical procedures are implanted with the Layer 7 device and use motion-capture gloves to perform gesture tasks.

The two studies plan to enrol up to 15 patients annually.

The Layer 7 Cortical Interface, which is currently an investigational device, is not commercially available in the US.

Precision Neuroscience chief science officer and co-founder Dr Ben Rapoport said: “Mount Sinai and Penn Medicine are major centres of excellence, known for spearheading advancements in neurotechnology.

“Each of our partners has focused on a unique area of applied neuroscience, and each study leverages the high-resolution neural data produced by our arrays to shed light on a different aspect of how the brain works.”

Last year, Precision Neuroscience said it successfully concluded the first-in-human procedures in a pilot clinical study of the Layer 7 Cortical Interface system.

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