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From Proof-of-Concept to Decision-Grade Cerebellar Neurostimulation: A Precision-and-Governance Pipeline for Globally
M Vijayasimha1, M Srikanth2, Pardeep Kumar3
1University Institute of Allied Health Science, Chandigarh University, Mohali, Punjab, 140413, India. vijaya.e19133@cumail.in.
Abstract:
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.
