Clinical Utility and Safety of an Ultrasonic Head Stimulator in Dementia With Lewy Bodies
Yuta Manabe
Alzheimer Disease & Associated Disorders 2024, 39, 33-38 · 10.1097/wad.0000000000000652
Abstract
Background The potential of Ultra-Ma, an ultrasonic head stimulator, for the supplementary treatment of dementia with Lewy bodies (DLB) was evaluated in patients with various symptoms under poor control by drug therapy. Methods Patients with DLB treated with choline esterase inhibitor or L-DOPA, either alone or in combination, and who met inclusion criteria were enrolled. Four weeks of placebo stimulation was followed by 8 weeks of active ultrasonic stimulation and a 4-week follow-up. Primary endpoints were the effects of ultrasonic head stimulation on both cognitive dysfunction and behavioral and psychological symptoms of dementia (BPSD). Cognitive dysfunction was evaluated using the Japanese versions of the Mini-Mental State Examination and Montreal Cognitive Assessment, and BPSD was assessed using the Neuropsychiatric Inventory Brief Questionnaire Form. For cognitive fluctuations, the Cognitive Fluctuation Inventory served as an index. Improvements in parkinsonism, activities of daily living, and caregiver burden were examined as secondary endpoints. Results Twelve patients were enrolled. The primary endpoint was significantly improved during the active stimulation period, as were secondary endpoint ratings for parkinsonism and caregiver burden. No notable adverse events occurred. Conclusions The findings suggest that ultrasonic head stimulation has supplementary potential when combined with drug treatment in DLB.
Abstract via europepmc.
Exposures
Exposure 1: Ultra-Ma ultrasonic head stimulation (active stimulation period)
Target: whole brain or unfocused — “head”
Device: other named manufacturer · Kamiyama Mfg. Co., Ltd. · Ultra-Ma (development code KMY-01) ✓
| Waveform | not reported | |
|---|---|---|
| Fundamental frequency (kHz) | 30 | ✓✓✓ |
| Pulse duration (ms) | not reported | |
| Pulse repetition frequency (Hz) | not reported | |
| Duty cycle (%) | not reported | |
| Sonication duration (s) | 1,200 | ✓✓✓ |
| Free-field pressure (kPa) | not reported | |
|---|---|---|
| Free-field Isppa (W/cm²) | 0.0016 | ✓✓✓⚑ |
| Free-field Ispta (W/cm²) | not reported | |
| In-situ estimate | not reported | |
| In-situ pressure (kPa) | not reported | |
| In-situ Isppa (W/cm²) | not reported | |
| In-situ Ispta (W/cm²) | not reported |
Four weeks of placebo stimulation was followed by 8 weeks of active ultrasonic stimulation and a 4-week follow-up period. Patients underwent ultrasonic stimulation using the ultrasonic head stimulator for 20 minutes per session, twice daily (session 1 at 10:00 AM +/- 2 h; session 2 at 3:00 PM +/- 2 h). A massage band supplying weak ultrasound to the head was connected to the main body of the device via the No. 1 output terminal jack during placebo stimulation and via the No. 2 output terminal jack during active stimulation.
Flags from extraction
exposures[0].free_field.isppa_w_cm2— Paper reports 'maximum output' and 'average output' in mW/cm² measured in water, but never uses the terms ISPPA or ISPTA; the maximum value is recorded here as the closest available spatial-peak intensity, and the spatially-averaged 0.71 mW/cm² value has no field to record it in.exposures[0].timing.waveform— The paper never describes whether the 30 kHz output is continuous or pulsed (no PRF, pulse duration or duty cycle given).n_sessions_per_subject— Paper states session frequency (twice daily, 20 min) and period lengths in weeks but never states a total session count; computing one would require arithmetic not shown in the text.sham_type— Placebo condition used a different output jack (No. 1) on the same device; the paper never explains what output, if any, that jack produced.conditions— Dementia with Lewy bodies is not in the closed vocabulary; recorded as other + condition_other.