Prospective Long-term Follow-up of Focused Ultrasound Unilateral Subthalamotomy for Parkinson Disease.

Aged Humans Middle Aged Deep Brain Stimulation Follow-Up Studies Parkinson Disease / diagnostic imaging Prospective Studies Quality of Life Subthalamic Nucleus Treatment Outcome

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
28 03 2023
Historique:
received: 13 04 2022
accepted: 17 11 2022
medline: 29 3 2023
pubmed: 12 1 2023
entrez: 11 1 2023
Statut: ppublish

Résumé

Unilateral magnetic resonance-guided focused ultrasound subthalamotomy (FUS-STN) has been shown to improve the cardinal motor features of Parkinson disease (PD). Whether this effect is sustained is not known. This study aims to report the long-term outcome of patients with PD treated with unilateral FUS-STN. We conducted a prospective open-label study of patients with asymmetrical PD who underwent unilateral FUS-STN. All patients were evaluated up to 36 months after treatment. The primary outcome was the difference from baseline to 36 months after FUS-STN in the score of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor part (III) for the treated hemibody in the off-medication state. The safety outcome included all adverse events occurring during follow-up. Secondary outcomes were the change in the MDS-UPDRS III score on-medication; subscores of rigidity, bradykinesia, tremor, and axial features; total MDS-UPDRS III; and the MDS-UPDRS part IV. Functional disability and quality of life were assessed using the MDS-UPDRS II and the PDQ39, respectively. Patient impression of change and satisfaction with the treatment were self-assessed. The Wilcoxon signed-rank test with subsequent Bonferroni's correction was used for data analysis. Thirty-two patients with PD were evaluated at 36 months after treatment. The mean (±SD) age at baseline was 56.0 ± 10.1 years, with a mean disease duration of 6.8 ± 2.8 years. The MDS-UPDRS III score for the treated hemibody off-medication was improved by 52.3% from baseline to 3 years (score reduction from 19.0 ± 3.2 to 8.9 ± 3.3, 95% CI 8.7 to 11.6, The benefit of unilateral FUS-STN on PD motor features is sustained in the long term. FUS-STN contributes to better clinical control over several years of evolution. NCT02912871/03454425. This study provides Class IV evidence on the utility of focused ultrasound unilateral subthalamotomy in the treatment of people with Parkinson disease.

Sections du résumé

BACKGROUND AND OBJECTIVES
Unilateral magnetic resonance-guided focused ultrasound subthalamotomy (FUS-STN) has been shown to improve the cardinal motor features of Parkinson disease (PD). Whether this effect is sustained is not known. This study aims to report the long-term outcome of patients with PD treated with unilateral FUS-STN.
METHODS
We conducted a prospective open-label study of patients with asymmetrical PD who underwent unilateral FUS-STN. All patients were evaluated up to 36 months after treatment. The primary outcome was the difference from baseline to 36 months after FUS-STN in the score of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor part (III) for the treated hemibody in the off-medication state. The safety outcome included all adverse events occurring during follow-up. Secondary outcomes were the change in the MDS-UPDRS III score on-medication; subscores of rigidity, bradykinesia, tremor, and axial features; total MDS-UPDRS III; and the MDS-UPDRS part IV. Functional disability and quality of life were assessed using the MDS-UPDRS II and the PDQ39, respectively. Patient impression of change and satisfaction with the treatment were self-assessed. The Wilcoxon signed-rank test with subsequent Bonferroni's correction was used for data analysis.
RESULTS
Thirty-two patients with PD were evaluated at 36 months after treatment. The mean (±SD) age at baseline was 56.0 ± 10.1 years, with a mean disease duration of 6.8 ± 2.8 years. The MDS-UPDRS III score for the treated hemibody off-medication was improved by 52.3% from baseline to 3 years (score reduction from 19.0 ± 3.2 to 8.9 ± 3.3, 95% CI 8.7 to 11.6,
DISCUSSION
The benefit of unilateral FUS-STN on PD motor features is sustained in the long term. FUS-STN contributes to better clinical control over several years of evolution. NCT02912871/03454425.
CLASSIFICATION OF EVIDENCE
This study provides Class IV evidence on the utility of focused ultrasound unilateral subthalamotomy in the treatment of people with Parkinson disease.

Identifiants

DOI: 10.1212/WNL.0000000000206771 PMID: 36631272 PMC: PMC10065206
pubmed: 36631272
pii: WNL.0000000000206771
doi: 10.1212/WNL.0000000000206771
pmc: PMC10065206
doi:

Banques de données

ClinicalTrials.gov
['NCT02912871', 'NCT03454425']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1395-e1405

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2023 American Academy of Neurology.

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Auteurs

Raúl Martínez-Fernández (R)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0002-0305-013X

Elena Natera-Villalba (E)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0001-5771-5005

Jorge U Máñez Miró (JU)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0002-8995-8340

Rafael Rodriguez-Rojas (R)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0002-2903-199X

Marta Marta Del Álamo (M)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.

José Ángel Pineda-Pardo (JÁ)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0002-8776-0031

Claudia Ammann (C)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0002-4717-8573

Ignacio Obeso (I)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain. jobeso.hmcinac@hmhospitales.com.
ORCID: 0000-0001-8783-7281

David Mata-Marín (D)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0003-1447-3872

Frida Hernández-Fernández (F)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.

Carmen Gasca-Salas (C)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0001-7411-8106

Michele Matarazzo (M)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.
ORCID: 0000-0002-2907-8667

Fernando Alonso-Frech (F)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain.

Jose A Obeso (JA)

From the HM CINAC (Centro Integral de Neurociencias Abarca Campal) (R.M.-F., E.N.-V., J.U.M.M., R.R.-R., M.D.A., J.A.P.-P., C.A., I.O., D.M.-M., F.H.-F., C.G.-S., M.M., F.A.-F., J.A.O.). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid; CIBERNED (R.M.-F., R.R.-R., J.A.P.-P., I.O., C.G.-S., J.A.O.), Instituto Carlos III, Madrid; San Pablo-CEU University Medical School (R.M.-F., J.A.O.), Madrid, Spain. J.U.M.M. is currently at the Department of Neurology, IMED Hospitales, Valencia and the Universidad Autónoma de Madrid University-Instituto Cajal, Madrid, Spain. jobeso.hmcinac@hmhospitales.com.
ORCID: 0000-0002-6996-8613

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Procédures de chirurgie opératoire › Stimulation cérébrale profonde › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études de suivi › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Maladies du système nerveux › Maladies neurodégénératives › Maladie de Parkinson › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Prospective Long-term Follow-up of Focused...
questionsmedicales.fr › Système nerveux › Système nerveux central › Encéphale › Prosencéphale › Diencéphale › Subthalamus › Noyau subthalamique › Prospective Long-term Follow-up of Focused...
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 › Prospective Long-term Follow-up of Focused...