BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
Funds the small clinical trial that settles a brain device's final design — early feasibility studies, from short procedures to chronic implants.
This is the second phase of the BRAIN Initiative's device programme: the small clinical trial itself.
The studies in scope range widely. They can be acute or short-term procedures that an Institutional Review Board judges Non-Significant Risk, or Significant Risk studies needing an Investigational Device Exemption from the FDA — a chronic implant, for instance. What they have in common is purpose…
Small clinical trials, including early feasibility studies, that answer key questions about the function or final design of recording and stimulating devices for central nervous system disorders — from acute Non-Significant Risk procedures to Significant Risk studies such as chronic implants requiring an Investigational Device Exemption.
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