Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2021 Nov;36(11):2653-2662.
doi: 10.1002/mds.28716. Epub 2021 Jul 20.

Bilateral Focused Ultrasound Thalamotomy for Essential Tremor (BEST-FUS Phase 2 Trial)

Christian Iorio-Morin  1   2 , Kazuaki Yamamoto  2 , Can Sarica  2 , Ajmal Zemmar  2   3 , Mathieu Levesque  4 , Simon Brisebois  5 , Jurgen Germann  2 , Aaron Loh  2 , Alexandre Boutet  2   6 , Gavin J B Elias  2 , Paula Azevedo  7 , Elizabeth Adam  1   2 , Urmi Patel  2 , Martha Lenis  2 , Suneil K Kalia  2   8 , Mojgan Hodaie  2 , Alfonso Fasano  7   8 , Andres M Lozano  2
Affiliations
Clinical Trial

Bilateral Focused Ultrasound Thalamotomy for Essential Tremor (BEST-FUS Phase 2 Trial)

Christian Iorio-Morin et al. Mov Disord. 2021 Nov.

Abstract

Background: In patients with medically refractory essential tremor, unilateral magnetic resonance-guided focused ultrasound thalamotomy can improve contralateral tremor. However, this procedure does not address ipsilateral symptoms.

Objective: The objective of the current study was to determine whether bilateral thalamotomies can be performed with an acceptable safety profile where benefits outweigh adverse effects.

Methods: We conducted a prospective, single-arm, single-blinded phase 2 trial of second-side magnetic resonance-guided focused ultrasound thalamotomy in patients with essential tremor. Patients were followed for 3 months. The primary outcome was the change in quality of life relative to baseline, as well as the answer to the question "Given what you know now, would you treat the second side again?". Secondary outcomes included tremor, gait, speech, and adverse effects.

Results: Ten patients were analyzed. The study met both primary outcomes, with the intervention resulting in clinically significant improvement in quality of life at 3 months (mean Quality of Life in Essential Tremor score difference, 19.7; 95%CI, 8.0-31.4; P = 0.004) and all patients reporting that they would elect to receive the second-side treatment again. Tremor significantly improved in all patients. Seven experienced mild adverse effects, including 2 with transient gait impairment and a fall, 1 with dysarthria and dysphagia, and 1 with mild dysphagia persisting at 3 months.

Conclusions: Staged bilateral magnetic resonance-guided focused ultrasound thalamotomy can be performed with a reasonable safety profile similar to that seen with unilateral thalamotomy and improves the tremor and quality of life of patients with essential tremor. Longer-term follow-up and continued accrual in the phase 3 trial will be required to validate these findings. © 2021 International Parkinson and Movement Disorder Society.

Keywords: essential tremor; focused ultrasounds; thalamotomy.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord 2010;25(5):534-541.
    1. Zesiewicz TA, Elble RJ, Louis ED, et al. Evidence-based guideline update: treatment of essential tremor: report of the Quality Standards subcommittee of the American Academy of Neurology. Neurology 2011;77(19):1752-1755.
    1. Dallapiazza RF, Lee DJ, Vloo PD, et al. Outcomes from stereotactic surgery for essential tremor. J Neurol Neurosurg Psychiatry 2019;90(4):474-482.
    1. Elias WJ, Lipsman N, Ondo WG, et al. A randomized trial of focused ultrasound thalamotomy for essential tremor. N Engl J Med 2016;375(8):730-739.
    1. Halpern CH, Santini V, Lipsman N, et al. Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor. Neurology 2019;93(24):e2284-e2293.

Publication types

LinkOut - more resources