Please use this identifier to cite or link to this item: http://hdl.handle.net/10637/15927

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


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Title: Skull Density Ratio as Arm-Allocation Parameter for a Controlled Focused Ultrasound Trial in Parkinson’s Disease
Authors : Pineda-Pardo, José A.
Martínez-Fernández, Raúl
Natera Villalba, Elena
Ruiz Yanzi, Agustina
Rodríguez Rojas, Rafael
Álamo, Marta del
Jiménez Castellanos, Tamara
Matarazzo, Michele
Gasca Salas, Carmen
Rasco, Olivier
Obeso Inchausti, José Ángel
Keywords: Parkinson, Enfermedad deTrastornos motoresFocused ultrasound
Publisher: Wiley
Citation: Pineda-Pardo, J.A., Martínez-Fern_andez, R., Natera-Villalba, E., Ruiz-Yanzi, A., Rodríguez-Rojas, R., Del Alamo, M., Jiménez-Castellanos, T., Matarazzo, M., Gasca-Salas, C., Rascol, O. and Obeso, J.A. (2024), Skull Density Ratio as Arm-Allocation Parameter for a Controlled Focused Ultrasound Trial in Parkinson's Disease. Mov Disord Clin Pract. https://doi.org/10.1002/mdc3.14040
Abstract: Background: 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: 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: 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: 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: 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.
URI: http://hdl.handle.net/10637/15927
Rights : http://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
Open Access
ISSN: 2330-1619
Supported by: Acuerdo Transformativo – 2024
Issue Date: 13-May-2024
Center : Universidad San Pablo-CEU
Appears in Collections:Medicina





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