Safety and Effectiveness of Unilateral MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Beijing GoBroad HospitalBeijing, ChinaContact: Ling ChenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- meishanshan
- Trial code
- NCT07006740
- Record updated
- 5 June 2025
- Original description
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.Read full original descriptionShow less
A Multicenter, Non-Randomized Controlled Observational Study on the Safety and Effectiveness of Unilateral MR-Guided Focused Ultrasound Thalamotomy for Essential Tremor
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.
Inclusion: Age ≥ 22 years; Diagnosis of essential tremor confirmed by clinical criteria; Medication-refractory tremor with significant functional impairment; Ability to provide informed consent; Willingness to undergo follow-up assessments for 12 months.
Exclusion: History of other neurological disorders (e.g., Parkinson's disease); Presence of unstable medical conditions (e.g., uncontrolled hypertension); Severe cognitive impairment or psychiatric illness; Contraindications to MRI (e.g., implanted metal devices); Pregnancy or breastfeeding.