Please use this identifier to cite or link to this item: http://hdl.handle.net/10637/15353
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dc.contributor.otherUniversidad San Pablo-CEU. Facultad de Medicina. Departamento de Ciencias Médicas Clínicas.-
dc.contributor.otherGrupo: HM Centro Integral de Neurociencia (HM CINAC)-
dc.contributor.otherCentro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED)-
dc.creatorMartínez-Fernández, Raúl-
dc.creatorMáñez-Miró, Jorge-
dc.creatorRodríguez Rojas, Rafael-
dc.creatorÁlamo, Marta del-
dc.creatorShah, B. B.-
dc.creatorHernández-Fernández, Frida-
dc.creatorPineda-Pardo, José A.-
dc.creatorMonje, Mariana H. G.-
dc.creatorFernández-Rodríguez, Beatriz-
dc.creatorSperling, S. A.-
dc.creatorMata-Marín, David-
dc.creatorGuida, Pasqualina-
dc.creatorAlonso-Frech, Fernando-
dc.creatorObeso Martín, Ignacio-
dc.creatorGasca Salas, Carmen-
dc.creatorVela Desojo, Lydia-
dc.creatorElias, W. J.-
dc.creatorObeso Inchausti, José Ángel-
dc.date.accessioned2024-02-05T15:21:45Z-
dc.date.available2024-02-05T15:21:45Z-
dc.date.issued2020-12-24-
dc.identifier.citationMartínez-Fernández R, Máñez-Miró JU, Rodríguez-Rojas R, Del Álamo M, Shah BB, Hernández-Fernández F, Pineda-Pardo JA, Monje MHG, Fernández-Rodríguez B, Sperling SA, Mata-Marín D, Guida P, Alonso-Frech F, Obeso I, Gasca-Salas C, Vela-Desojo L, Elias WJ, Obeso JA. Randomized Trial of Focused Ultrasound Subthalamotomy for Parkinson's Disease. N Engl J Med. 2020 Dec 24;383(26):2501-2513. doi: 10.1056/NEJMoa2016311. PMID: 33369354.es_ES
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10637/15353-
dc.description.abstractBACKGROUND The subthalamic nucleus is the preferred neurosurgical target for deep-brain stimulation to treat cardinal motor features of Parkinson’s disease. Focused ultrasound is an imaging-guided method for creating therapeutic lesions in deep-brain structures, including the subthalamic nucleus. METHODS We randomly assigned, in a 2:1 ratio, patients with markedly asymmetric Parkinson’s disease who had motor signs not fully controlled by medication or who were ineligible for deep-brain stimulation surgery to undergo focused ultrasound subthalamotomy on the side opposite their main motor signs or a sham procedure. The primary efficacy outcome was the between-group difference in the change from baseline to 4 months in the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) motor score (i.e., part III) for the more affected body side (range, 0 to 44, with higher scores indicating worse parkinsonism) in the off-medication state. The primary safety outcome (procedure-related complications) was assessed at 4 months. RESULTS Among 40 enrolled patients, 27 were assigned to focused ultrasound subthalamotomy (active treatment) and 13 to the sham procedure (control). The mean MDS-UPDRS III score for the more affected side decreased from 19.9 at baseline to 9.9 at 4 months in the active-treatment group (least-squares mean difference, 9.8 points; 95% confidence interval [CI], 8.6 to 11.1) and from 18.7 to 17.1 in the control group (least-squares mean difference, 1.7 points; 95% CI, 0.0 to 3.5); the between-group difference was 8.1 points (95% CI, 6.0 to 10.3; P<0.001). Adverse events in the active-treatment group were dyskinesia in the off-medication state in 6 patients and in the on-medication state in 6, which persisted in 3 and 1, respectively, at 4 months; weakness on the treated side in 5 patients, which persisted in 2 at 4 months; speech disturbance in 15 patients, which persisted in 3 at 4 months; facial weakness in 3 patients, which persisted in 1 at 4 months; and gait disturbance in 13 patients, which persisted in 2 at 4 months. In 6 patients in the activetreatment group, some of these deficits were present at 12 months. CONCLUSIONS Focused ultrasound subthalamotomy in one hemisphere improved motor features of Parkinson’s disease in selected patients with asymmetric signs. Adverse events included speech and gait disturbances, weakness on the treated side, and dyskinesia. (Funded by Insightec and others; ClinicalTrials.gov number, NCT03454425.)en_EN
dc.formatapplication/pdf-
dc.language.isoen-
dc.publisherMassachusetts Medical Society-
dc.relation.ispartofNew England Journal of Medicine-
dc.rightshttp://creativecommons.org/licenses/by-nc-nd/4.0/deed.es-
dc.subjectDeep-brain stimulationen_EN
dc.subjectParkinson's diseaseen_EN
dc.subjectFocused ultrasounden_EN
dc.titleRandomized Trial of Focused Ultrasound Subthalamotomy for Parkinson’s Diseaseen_EN
dc.typeArtículoes_ES
dc.identifier.doi10.1056/NEJMoa2016311-
dc.relation.projectIDSupported by Insightec, the Focused Ultrasound Foundation, Fundación MAPFRE, Fundación Hospitales de Madrid, and the University of Virginia Center of Excellence.-
dc.centroUniversidad San Pablo-CEU-
Appears in Collections:Medicina




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