Skull Density Ratio as Arm-Allocation Parameter for a Controlled Focused Ultrasound Trial in Parkinson's Disease.

Autor:	Pineda-Pardo JA; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain., Martínez-Fernández R; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain., Natera-Villalba E; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain.; PhD Medicine Program, Universidad Autonoma de Madrid, Madrid, Spain., Ruiz-Yanzi A; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain., Rodríguez-Rojas R; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain.; Facultad HM de Ciencias de la Salud de la Universidad Camilo José Cela, Madrid, Spain., Del Alamo M; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain., Jiménez-Castellanos T; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain.; Department of Preventive Medicine, Public Health and Microbiology, Universidad Autónoma de Madrid, Madrid, Spain., Matarazzo M; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain., Gasca-Salas C; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain.; Universidad San Pablo-CEU, Madrid, Spain., Rascol O; Clinical Investigation Center CIC 1436, NS-Park/F-CRIN Network and NeuroToul COEN Center; Inserm, University of Toulouse 3 and CHU of Toulouse, F-31000, Toulouse, France., Obeso JA; HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal). Hospital Universitario HM Puerta del Sur, HM Hospitales, Madrid, Spain.; CIBERNED, Instituto de Salud Carlos III, Madrid, Spain.; Instituto de Investigación Sanitaria HM Hospitales, Spain.; Universidad San Pablo-CEU, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	Movement disorders clinical practice [Mov Disord Clin Pract] 2024 Jul; Vol. 11 (7), pp. 825-829. Date of Electronic Publication: 2024 May 13.
DOI:	10.1002/mdc3.14040
Abstrakt:	Background: MR-guided focused ultrasound (FUS) thermoablation is an established therapy for movement disorders. FUS candidates must meet a predefined threshold of skull density ratio (SDR), a parameter that accounts for the efficiency in reaching ablative temperatures. Randomized sham-controlled trials to provide definitive therapeutic evidence employ pure randomization of subjects into active treatment or control arms. The latter design has several general limitations. Objective: To demonstrate that SDR values are not associated with clinically and demographically relevant variables in patients with Parkinson's disease (PD). This in turn would allow using SDR as an arm-allocation parameter, separating patients who will receive active FUS treatment and best medical management treatment (BMT). Methods: We studied a cohort of 215 PD patients who were candidates for FUS subthalamotomy to determine if the SDR was correlated with demographic or clinical variables that could introduce bias for group allocation in a controlled trial. Results: SDR was unassociated with age, gender, and clinical motor features nor with levodopa daily dose in our cohort of PD patients. A negative association with age was found for the female subgroup. Conclusions: Our results show that in a PD population considered for FUS subthalamotomy treatment, the SDR may be a valid group-allocation parameter. This could be considered as the basis for a controlled study comparing FUS subthalamotomy vs BMT. (© 2024 The Authors. Movement Disorders Clinical Practice published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
Databáze:	MEDLINE
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