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

Essential Tremor / surgery Humans Magnetic Resonance Imaging / methods Prospective Studies Quality of Life Thalamus / surgery Treatment Outcome
essential tremor focused ultrasounds thalamotomy

Journal

Movement disorders : official journal of the Movement Disorder Society
ISSN: 1531-8257
Titre abrégé: Mov Disord
Pays: United States
ID NLM: 8610688

Informations de publication

Date de publication:
11 2021
Historique:
revised: 21 06 2021
received: 02 04 2021
accepted: 22 06 2021
pubmed: 22 7 2021
medline: 17 3 2022
entrez: 21 7 2021
Statut: ppublish

Résumé

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. 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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1002/mds.28716 PMID: 34288097
pubmed: 34288097
doi: 10.1002/mds.28716
doi:

Types de publication

Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2653-2662

Informations de copyright

© 2021 International Parkinson and Movement Disorder Society.

Références

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Auteurs

Christian Iorio-Morin (C)

Division of Neurosurgery, Department of Surgery, Université de Sherbrooke, Sherbrooke, Québec, Canada.
Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
ORCID: 0000-0003-2995-7255

Kazuaki Yamamoto (K)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Can Sarica (C)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Ajmal Zemmar (A)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Department of Neurosurgery, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Henan University People's Hospital, Henan University School of Medicine, Zhengzhou, China.

Mathieu Levesque (M)

Division of Neurology, Department of Medicine, Université de Sherbrooke, Sherbrooke, Québec, Canada.

Simon Brisebois (S)

Division of Otolaryngology - Head & Neck Surgery, Department of Surgery, Université de Sherbrooke, Sherbrooke, Québec, Canada.

Jurgen Germann (J)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Aaron Loh (A)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Alexandre Boutet (A)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Joint Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada.

Gavin J B Elias (GJB)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Paula Azevedo (P)

Edmond J. Safra Program in Parkinson's Disease, Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, UHN, Toronto, Ontario, Canada. Division of Neurology, University of Toronto, Toronto, Ontario, Canada.

Elizabeth Adam (E)

Division of Neurosurgery, Department of Surgery, Université de Sherbrooke, Sherbrooke, Québec, Canada.
Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Urmi Patel (U)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Martha Lenis (M)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Suneil K Kalia (SK)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Krembil Brain Institute, Toronto, Ontario, Canada.

Mojgan Hodaie (M)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Alfonso Fasano (A)

Edmond J. Safra Program in Parkinson's Disease, Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, UHN, Toronto, Ontario, Canada. Division of Neurology, University of Toronto, Toronto, Ontario, Canada.
Krembil Brain Institute, Toronto, Ontario, Canada.

Andres M Lozano (AM)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

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Classifications MeSH

questionsmedicales.fr › Maladies du système nerveux › Maladies du système nerveux central › Troubles de la motricité › Tremblement essentiel › Bilateral Focused Ultrasound Thalamotomy for...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Bilateral Focused Ultrasound Thalamotomy for...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Imagerie par résonance magnétique › Bilateral Focused Ultrasound Thalamotomy for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Bilateral Focused Ultrasound Thalamotomy for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Bilateral Focused Ultrasound Thalamotomy for...
questionsmedicales.fr › Système nerveux › Système nerveux central › Encéphale › Prosencéphale › Diencéphale › Thalamus › Bilateral Focused Ultrasound Thalamotomy for...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Bilateral Focused Ultrasound Thalamotomy for...