Characterization of focused ultrasound blood-brain barrier disruption effect on inflammation as a function of treatment parameters.

The technology of focused ultrasound-mediated disruption of the blood-brain barrier (FUS-BBB opening) has now been used in over 20 Phase 1 clinical trials to validate the safety and feasibility of BBB opening for drug delivery in patients with brain tumors and neurodegenerative diseases. The primary treatment parameters, FUS intensity and microbubble dose, are chosen to balance sufficient BBB disruption to achieve drug delivery against potential acute vessel damage leading to microhemorrhage. However, other safety considerations due to second order effects caused by BBB disruption, such as inflammation and alteration of neurovascular function, are only beginning to be understood.

Characterization of focused ultrasound blood-brain barrier disruption effect on inflammation as a function of treatment parameters.

The technology of focused ultrasound-mediated disruption of the blood-brain barrier (FUS- BBB opening) has now been used in over 20 Phase 1 clinical trials to validate the safety and feasibility of BBB opening for drug delivery in patients with brain tumors and neurodegenerative diseases. The primary treatment parameters, FUS intensity and microbubble dose, are chosen to balance sufficient BBB disruption to achieve drug delivery against potential acute vessel damage leading to microhemorrhage. This can largely be achieved based on both empirical results from animal studies and by monitoring the microbubble cavitation signal in real time during the treatment.