Long-term brain pressure monitoring via a discrete microimplant; a first-in-human safety and initial efficacy trial in adults and children with hydrocephalus.

Emerging neurotechnologies such as brain-computer interfaces and implantable sensors offer considerable promise in the treatment of a broad range of neurological conditions. The key challenges are reducing the implant size, powering it, and confirming long-term accuracy and safety. Here we report the development of a novel type of implantable medical device that measures intracranial pressure long term and which weighs only 0.28 g. Currently the management of hydrocephalus patients relies heavily on non-specific symptoms e.g. headache and there is a lack of actionable data to drive decisions that are not solely hospital based such as imaging. The implant is designed to sit within the cerebral cortex. In a group of 10 adults and 10 children with hydrocephalus we demonstrated that the device was safe and capable of remotely monitoring intracranial pressure in patients at home for up to 18 months (ClinicalTrial.gov NCT06402786). In several children shunt failures occurred and these were associated with raised ICP. Instead of relying on non-specific symptoms such as headache, physicians were able to obtain real-time intracranial pressure readings that can lead to changes in the management of these complex patients.