Safety and Effectiveness of Unilateral MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor

Sponsor
meishanshan
Study ID
NCT07006740
Status
Not Yet Recruiting

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Conditions

  • Essential Tremor

Eligibility Criteria

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

Interventions

  • MR-guided Focused Ultrasound Thalamotomy — PROCEDURE
    This intervention involves a unilateral magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy targeting the ventral intermediate nucleus (VIM) of the thalamus. The procedure is non-invasive and uses MRI guidance to deliver focused ultrasound energy to ablate the target area. It is performed without surgical incisions or implanted devices. The intervention is intended for patients with medication-refractory essential tremor. Participants receiving this intervention will be followed for 12 months to assess efficacy and safety.

Study Details

Essential tremor (ET) is one of the most common movement disorders, significantly impacting patients' quality of life. Many patients do not respond well to medication or cannot tolerate side effects, leaving limited treatment options. Magnetic Resonance-guided Focused Ultrasound (MRgFUS) is a noninvasive, targeted therapy that offers a promising alternative to surgical procedures such as deep brain stimulation. This study is a multicenter, non-randomized controlled observational study designed to evaluate the safety and effectiveness of unilateral MRgFUS thalamotomy targeting the ventral intermediate nucleus (VIM) in patients with medication-refractory essential tremor. Participants will be divided into two groups based on clinical evaluation and patient preference: the treatment group receiving MRgFUS and the control group receiving standard medical therapy. Both groups will undergo regular follow-up for one year. The primary outcome is improvement in tremor severity as measured by the Fahn-Tolosa-Marin Tremor Rating Scale and the Clinical Rating Scale for Tremor. Secondary outcomes include quality of life, cognitive and emotional status, and treatment-related adverse events. Eligible participants are adults aged 22 years or older who have a confirmed diagnosis of essential tremor and are significantly impaired despite medication. The goal is to assess whether MRgFUS provides sustained tremor relief and improves quality of life in comparison to standard care, while maintaining an acceptable safety profile.

Key Dates

First listed
Jun 5, 2025
Start date
Jun 10, 2025
Status verified
May 2025
Primary completion
Jun 10, 2026
Completion
Jun 10, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: MRgFUS Group
    Participants in this group will undergo unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy targeting the ventral intermediate nucleus (VIM) of the thalamus. The procedure is non-invasive and performed under MRI guidance. Subjects will be followed prospectively for 12 months to assess changes in tremor severity, quality of life, and safety outcomes.
  • Arm: Medical Therapy Group
    Participants in this group will receive standard medical therapy for essential tremor, which may include beta-blockers (such as propranolol), primidone, or other clinically indicated medications. Treatment plans will be determined by the attending physicians according to routine clinical practice. Participants will be followed for 12 months to assess changes in tremor severity, quality of life, and safety outcomes, consistent with the surgical treatment group.

Primary Outcome Measure

Change in Tremor Severity Assessed by the Fahn-Tolosa-Marin Tremor Rating Scale (FTM) [ Time Frame: Baseline and 12 months ]

Central Contacts

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