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. Author manuscript; available in PMC: 2023 Dec 1.
Published in final edited form as: Adv Drug Deliv Rev. 2022 Oct 19;191:114583. doi: 10.1016/j.addr.2022.114583

Table 2.

Summary of all currently-registered clinical trials of FUS-mediated BBB opening in human patients, separated by disease condition.

Disease / condition Study ID No. of patients Outcome measures FUS device Complete?
Alzheimer’s disease NCT04118764 6 Efficacy of BBBO
No. of safety events
Change in amyloid uptake
Change in cognitive function
Neuronavigation-guided system No
NCT04526262 6 Adverse events
Efficacy of BBBO
ExAblate 4000 Type 2 No
NCT02986932 6 Efficacy of BBBO
Change in amyloid uptake
Adverse events
Change in cognitive function
ExAblate 4000 Type 2 Yes
NCT03739905 30 Adverse events
Efficacy of BBBO
Change in cognitive function
Change in amyloid uptake
ExAblate 4000 Type 2 No
NCT04526262 6 Adverse events
Efficacy of BBBO
ExAblate 4000 Type 2 Yes
Parkinson’s disease NCT03608553 10 Adverse events
Feasibility of BBBO
ExAblate 4000 Type 2 No
NCT04370665 4 Efficacy of BBBO
Adverse events
Efficacy of Cerezyme delivery
ExAblate 4000 Type 2 No
Brain tumors NCT02343991 10 Adverse events ExAblate 4000 Type 2 Yes
NCT03551249 20 Adverse events
Feasibility of repeated BBBO
ExAblate 4000 Type 2 No
NCT04063514 15 Adverse events
Functional magnetic resonance imaging
DWL or Brainsonix No
NCT04804709 3 Adverse events
Survival
Efficacy of BBBO
Neuronavigation-guided system No
NCT03616860 20 Adverse events
Feasibility of repeated BBBO
Efficacy of BBBO
ExAblate 4000 Type 2 No
NCT04998864 5 Adverse events
Feasibility of repeated BBBO
ExAblate 4000 Type 2 No
NCT03714243 10 Adverse events
Efficacy of BBBO
ExAblate 4000 Type 2 No
NCT04440358 50 Adverse events
Efficacy of BBBO
ExAblate 4000 Type 2 No
NCT04417088 30 Adverse events
Efficacy of BBBO
ExAblate 4000 Type 2 No
NCT03712293 10 Adverse events
Efficacy of BBBO
ExAblate 4000 Type 2 No
NCT03626896 6 Adverse events
Dose limiting toxicity
Efficacy of BBBO
NaviFUS Yes
NCT04446416 10 Adverse events
Survival
Clinical response
Efficacy of BBBO
NaviFUS No
NCT03744026 33 Dose limiting toxicity
Efficacy of BBBO
SonoCloud-9 Yes
Amyotrophic lateral sclerosis NCT03321487 8 Adverse events
Efficacy of BBBO
ExAblate 4000 Type 2 Yes