Systematic Literature Review on Staged-bilateral MRI-guided High-intensity Focused Ultrasound for Treatment of Essential Tremor
Angeles Sanchez Fraga1, Lindsay Knight2, Ian Pyle2, Regina Martuscello2, Katie Gant2, Augusto Grinspan2, Cyril Ferrer1
1Insightec Europe GmBH, 2Insightec Inc.
Objective:
To systematically evaluate the clinical effectiveness, safety, cognition and quality of life following staged-bilateral magnetic resonance–guided focused ultrasound(MRgFUS) thalamotomy in patients with medication-refractory essential tremor(ET).
Background:
Essential tremor, the most common movement disorder, presents bilaterally and is known to be disabling and poorly controlled by pharmacological therapy. Unilateral MRgFUS has been established and is endorsed as an effective, incisionless treatment. With the approval of staged-bilateral MRgFUS, evidence and adoption of second-side procedures have grown. Understanding the evolving literature landscape of staged-bilateral MRgFUS is essential for optimizing patient outcomes.
Design/Methods:
A systematic literature review was conducted across Medline, Embase, and the Cochrane Library through February 2025, supplemented by searches of clinical trial registries. Eligible studies included adult ET patients undergoing bilateral MRgFUS. Data extraction and critical appraisal were performed using the JBI checklist for quasi-experimental studies. Outcomes included tremor severity(Clinical Rating Scale for Tremor, CRST), quality of life(QUEST, EQ-5D-5L), cognitive function, adverse events, and patient satisfaction. <br bcx8"="">
Results:
Six before-and-after studies (n=3–51; 2016–2024) met inclusion criteria. Staged-Bilateral MRgFUS significantly reduced tremor severity, with mean CRST score reductions of 66–81%, and functional disability(CRST Part C) improving by up to 73%. Quality-of-life scores(QUEST) improved by 81%, and EQ-5D-5L visual analog scale scores increased significantly post-treatment. No study reported significant cognitive decline. Adverse effects, most commonly gait impairment, dysgeusia, or transient sensory changes, were generally mild and self-limiting. Patient satisfaction was high, with most participants willing to repeat the procedure.
Conclusions:
2nd side MRgFUS is an approved, incisionless treatment for medication-refractory ET, producing sustained tremor and disability reduction with favorable safety and quality-of-life outcomes. While mostly mild transient side effects are common, no major long-term neurological or cognitive complications have been reported. An ongoing randomized controlled trial(NCT06974916) will further help confirm these findings and further work should be carried to help understand its real-world use.
10.1212/WNL.0000000000216888
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