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

Essential tremor (ET) is a progressive neurological disorder characterized primarily by action tremor affecting the upper limbs, head, or voice. Although ET is commonly treated with medications such as beta-blockers and anticonvulsants, a significant proportion of patients are either refractory to or intolerant of pharmacologic therapies. For these patients, surgical interventions such as deep brain stimulation (DBS) or thalamotomy may be considered. However, these procedures are invasive and associated with considerable risks and costs.

Magnetic resonance-guided focused ultrasound (MRgFUS) is a novel, non-invasive technology that enables precise thermal ablation of brain targets, such as the ventral intermediate nucleus (VIM) of the thalamus, under real-time MRI guidance. MRgFUS offers advantages such as immediate effect, no need for implants, and lower complication rates.

This multicenter, non-randomized, controlled observational study aims to evaluate the real-world effectiveness and safety of unilateral MRgFUS VIM thalamotomy in patients with medication-refractory ET. Patients will be allocated into treatment or control groups based on clinical judgment and patient preference. The study will focus on assessing improvements in tremor severity, quality of life, and treatment safety over a 12-month follow-up period. The findings will provide evidence on the utility of MRgFUS as a non-invasive therapeutic option and help inform future clinical decision-making for ET management.

Inclusion criteria

• 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 criteria

• History of other neurological disorders (e.g., Parkinson's disease)
• Presence of unstable medical conditions (e.g., uncontrolled hypertension)
• Contraindications to MRI (e.g., implanted metal devices)
• Severe cognitive impairment or psychiatric illness
• Pregnancy or breastfeeding