From Proof-of-Concept to Decision-Grade Cerebellar Neurostimulation: A Precision-and-Governance Pipeline for Globally Scalable Balance Interventions
摘要
The future of cerebellar stimulation should be moving out of the well-resourced research environment, so implementation needs to expect regulation, home-based models, and popular trust. An example of how a change in policy can affect the feasibility, cost and innovation schedule is the European reclassification of some non-medical NIBS devices as Class III medical devices [1]. There is also evidence in the literature of stakeholder research suggesting that parties concerned with the perceived benefit, with safety and with fear of misuse, affect the acceptability-variables that can dictate trial participation and ultimate adoption.