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 |