3 results
Establish the technical feasibility and safety of implantation of the investigational device, adjustment of the investigational device post-implantation and the ability of the investigational device to reduce mitral valve regurgitation.
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
Determine the priming effect on the epileptic brain of tVNS, to make it more susceptible to treatment with Brivaracetam (BRV), an AED. In addition, we aim to visualize these changes in the brain because of priming, possibly altered network-…