Study

Condition & Participants

Device & Treatment Specifications

Key Findings

Lipsman, et al. [59]

Alzheimer's Disease (6 patients)

Used ExAblate helmet array with microbubble injections; two sessions spaced one month apart. Parameters: 220 kHz frequency, 4.5 W power (50% of cavitation threshold). Target Area: Right frontal lobe (DLPFC), volume: 1 cm³

MRI with gadolinium contrast confirmed BBB opening, which closed within 24 hours. No serious adverse events; one patient had temporary neuropsychiatric symptoms, and two patients had transient gradient echo changes, possibly indicating microhemorrhages. No significant change in amyloid levels was observed at the targeted site on PET scans.

Park, et al. [100]

Alzheimer's Disease (6 patients)

Applied ExAblate helmet array with microbubble infusion, two treatments three months apart. Parameters: 220 kHz frequency, 8-40 W power, targeting a cavitation level of 0.4-0.65. Target Area: Bilateral frontal lobes, volume: 21 cm³

No adverse events were noted. BBB opening was confirmed in 96% of the targeted region by MRI with gadolinium contrast. A 1.6% reduction in amyloid levels was observed in the frontal lobes on PET imaging, with MMSE scores remaining stable and a temporary improvement in neuropsychiatric symptoms.

Epelbaum, et al. [104]

Alzheimer's Disease (10 patients)

Utilized SonoCloud implantable device with microbubble injections, seven sessions every two weeks. Parameters: 1 MHz frequency, 0.9-1.03 MPa pressure, Implant Site: Left supramarginal gyrus, device explanted after 9 months

One patient withdrew due to difficulty activating the device caused by a thick scalp. Another patient experienced a remote hemorrhage leading to acute delirium. Each session lasted 4.5 minutes. A non-significant reduction in amyloid levels was noted around the implant site.

Meng, et al. [60]

Alzheimer's Disease (9 patients)

Employed ExAblate helmet array with microbubble infusion, three sessions two weeks apart. Parameters: 220 kHz frequency, 50% of cavitation threshold power. Target Areas: Default Mode Network (DMN), including bilateral precuneus, anterior cingulate cortex (ACC), and hippocampi (initially unilateral, later bilateral); volume: 9 cm³

BBB opening was successfully achieved without serious adverse events. Two patients experienced acute confusion, with one case lasting a week, leading to that patient being excluded from further procedures. Immediate gradient echo changes were observed in two patients, which resolved the next day. A small but significant reduction in beta amyloid was detected in the sonicated right parahippocampal/inferior temporal region via PET imaging.

Rezai, et al. [105]

Alzheimer's Disease (10 patients)

Deployed ExAblate helmet array with microbubble injections/infusions, three sessions two weeks apart. Parameters: 220 kHz frequency, initial target: Unilateral hippocampus/entorhinal cortex (EC), later expanded to include frontal and parietal regions (up to 30 cm³)

No serious adverse events were reported. One patient developed hippocampal edema, which resolved within 72 hours. MRI-Gad showed BBB opening in 82% of the targeted brain volume, with closure within 24-48 hours. Cognitive assessments (ADAS-Cog/MMSE) showed stable cognition at 6 months and a mild decline at 12 months, consistent with expected progression.

Rezai, et al. [102]

Alzheimer's Disease (3 patients)

Used ExAblate helmet array with microbubble infusions, six monthly treatments paired with aducanumab infusion 2 hours prior. Parameters: 220 kHz frequency, Target Areas: Patient 1: right frontal lobe (10 mL), Patient 2: left frontal/parietal lobe (20 mL), Patient 3: left frontal/parietal/temporal lobes & hippocampus (40 mL)

Patient 3 showed cognitive decline after 30 days, without affecting daily activities. A significant reduction in amyloid levels was observed in the treated regions compared to baseline and untreated contralateral areas on PET imaging.