A Study to Evaluate the Safety and Efficacy of Staged Bilateral Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for the Treatment of Essential Tremor

Sponsor
Chinese PLA General Hospital
Study ID
NCT06676501
Status
Enrolling By Invitation

Conditions

  • Essential Tremor
  • Essential Tremor, Movement Disorders

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ExAblate — PROCEDURE
    Transcranial focused ultrasound thalamotomy

Study Details

The objective of this prospective, single-arm, open-label study is to asses the safety and efficacy of the staged bilateral thalamotomy using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd.

Key Dates

First listed
Nov 6, 2024
Start date
Sep 26, 2024
Status verified
Nov 2024
Primary completion
Jun 1, 2025
Completion
Nov 1, 2026

Study Design

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

Arms

  • Experimental: ExAblate Treatment
    Participants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS

Primary Outcome Measure

Number of Device and Procedure Related Adverse Events [ Time Frame: 2 Years post treatment ]

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