Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.

Sponsor
National Taiwan University Hospital
Study ID
NCT07172295
Status
Recruiting
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Conditions

  • Continuous Theta Burst Stimulation Transcranial Focused Ultrasound
  • Dystonic Tremor
  • Essential Tremor
  • Parkinson Disease (PD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Accelerated NaviFUS-ctbFUS stimulation — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Sep 15, 2025
Start date
Jun 11, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tremor treatment

Primary Outcome Measure

Incidence of Adverse Events Compared to Baseline [Safety Assessment] [ 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. ]

Central Contacts

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