The study plans to recruit 12 patients with Parkinsonian tremor, essential tremor, or dystonic tremor. After receiving NaviFUS-ctbTUS stimulation, the improvement in their tremor will be recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Three consecutive sessions of NaviFUS-ctbTUS stimulation were performed, with a 5-minute interval between each session. The acoustic pressure was set such that the estimated intracranial pressure at 30% skull transmission was approximately 0.5 MPa. The stimulation target was the center of the Vop, with a total of 7 stimulation points.
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Hsinchu City, Taiwan
RECRUITINGIncidence of Adverse Events Compared to Baseline [Safety Assessment]
The safety of using the NaviFUS system in patients with tremor will be assessed throughout the study period. Any examination result that shows a significant change compared to baseline (Visit 1), as determined by the investigator, will be documented and reported as an adverse event (AE).
Time frame: Day of first stimulation, 7 days after first stimulation, day of second stimulation, 7 days after second stimulation, and 28 days after second stimulation.
Change in Tremor Amplitude [Efficacy]
Efficacy will be assessed by determining whether there is a change in tremor amplitude across multiple time points following treatment. Measurements (archimedes spirogram ) will be taken pre-treatment and at several time points post-treatment to evaluate immediate and short-term effects.
Time frame: On the day of first stimulation and the day of second stimulation: immediately before treatment, and at 0, 20, 40, and 60 minutes post-treatment; on the day of second stimulation, also after task-based fMRI.
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