Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study
Fecha de publicación:
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Santos-García D.
- González-Ortega G.
- Sánchez-Alonso P.
- Planas-Ballvé A.
- García-Ramos R.
- Cabo I.
- Blázquez-Estrada M.
- Sánchez-Ferro Á.
- Paz González J.M.
- Cores Bartolomé C.
- Samaniego Vinueza L.B.
- Solleiro Vidal Á.
- Álvarez Sauco M.
- Freire Álvarez E.
- Martínez Castrillo J.C.
- Pareés Moreno I.
- Fanjul Arbos S.
- Perona Moratalla A.B.
- Legarda Ramírez I.
- Vives Pastor B.
- Valero García M.F.
- Cubo Delgado E.
- López Ariztegui N.
- Morales Casado M.I.
- Tabar Comellas G.
- Alonso Modino D.
- Lorenzo Brito J.N.
- Rojas Pérez E.
- Cabo Complejo I.
- De Aguilar Pensado A.R.
- Hernández Vara J.
- González M.V.
- Belmonte S.
- Romero Fábrega J.C.
- Escamilla Sevilla F.
- Triguero Cueva L.
- Madrid Navarro C.J.
- Yáñez Baña R.
- Ávila Rivera A.
- Caballol Pons N.
- Peral Quirós A.
- Lozano D.
- Rábano Suárez P.
- Méndez Guerrero A.
- Pérez Rangel D.
- Valldeoriola Serra F.
- Fernández Revuelta A.
- López Valdés E.
- Ribacoba Díaz C.
- Martínez-Torres I.
- Sánchez Alonso P.
- Novo Ponte S.
- Gamo González E.
- Martín García R.
- Mir P.
- Muñoz Delgado L.
- Adarmes Gómez A.D.
- Ojeda Lepe E.
- Jesús Maestre S.
- MacÍas García D.
- Carrillo García F.
- Castellano Guerrero A.M.
- San Eufrasio Martínez M.
- Pérez Calvo C.
- García Herruzo A.
- Gómez Rapela C.
- Garrote Espina L.
- Suárez San Martín E.
- García Fernández C.
- Prendes Fernández P.
- García Ruíz Espiga P.
- Feliz Feliz C.
- Espinosa Rosso R.
- Mauri Fabrega L.
- Kulisevsky Bojarski J.
- Pascual Sedano B.
- Pagonabarraga J.
- Campolongo A.
- Mata Álvarez-Santullano M.
- Gómez Esteban J.C.
- Fernández Valle T.
- Ruiz López M.
- Tijero Merino B.
- López Manzanares L.
- Muro Hospital I.
- Casas Peña E.
- Lorenzo Barreto P.
- Gil Villar M.P.
- Sancho Saldana A.
- Quibus Requena L.
- Olivares Romero J.
- Rebollo Lavado B.
- Gómez Mayordomo V.
- Solano Vila B.
- Cots Foraster A.
- López Dominguez D.
- Vivas Villacampa L.
- González Ardura J.
- Castaño García B.
- Sánchez Rodríguez A.
- Escalante Arroyo S.
- Delgado Ballestero T.
- Cerdán Santacruz D.M.
- Mendoza Rodríguez A.
- Castrillo Sanz A.
- Caballero Sánchez L.
- Gómez López De San Román C.
- Fernández-Pajarín G.
- Casanova Mollá J.
- Monterde Ortega Á.
- Cantarero Duque S.
- Fernández Rodríguez B.
- Muñoz Ruíz T.
- Martí Andrés G.
- Clavero Ibarra P.
- Erdocia Goñi A.
- López Veloso A.C.
- González Hernández A.N.
- Guerra Hiraldo J.D.
- Rashid López R.
- Martí Martínez S.
- Aneiros Díaz Á.
- Vela L.
- Ruíz Martínez J.
- Mondragón Rezola E.
- Vinagre Aragón A.
- Gutiérrez García J.
- López Blanco R.
Grupos
Abstract
Background and objective Device-aided therapies (DATs) are treatments indicated for people with Parkinson's disease (PwP) experiencing clinical fluctuations that remain suboptimal despite conventional medication. New DATs have recently emerged such as levodopa-entacapone-carbidopa intestinal gel infusion (LECIG) and subcutaneous infusion of foslevodopa/foscarbidopa (fLD/fCD). Understanding the differences between various DATs is essential. Patients and Methods We present here the protocol study of the DATs-PD GETM Spanish Registry. This is a descriptive, observational, prospective, multicenter, open study that is proposed as a clinical registry with progressive inclusion of PwP treated with a DAT in daily clinical practice conditions in more 40 centers from Spain for 10 years. The principal aim is to know the type of DAT that PwP in our country (Spain) receive. Specific objectives are to compare the clinical characteristics of the patients, the effectiveness, safety and tolerability, to identify predictors of a good response and to analyze the response by groups (gender, disease duration, phenotype, etc.). There is a baseline visit (V1; indication of the therapy), start visit (V2; initiation of the therapy) and follow-up visits at 6 months ± 3 months (V3_6M) and after this annually ± 3 months for 10 years (V3_12M, V3_24M, etc.). Results The registry is on going. The first patient was included on April 10, 2024. Patient recruitment and follow-up will be conducted until 31/DEC/2033. It is estimated that the registry will include a minimum of 3,000 patients. Conclusion The present study will help improve the care of PD patients treated with a DAT. © 2025 Santos-García et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Datos de la publicación
- ISSN/ISSNe:
- 1932-6203, 1932-6203
- Tipo:
- Article
- Páginas:
- -
- PubMed:
- 40163422
- Enlace a otro recurso:
- www.scopus.com
- Factor de Impacto:
- 0,852 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
PLoS One PUBLIC LIBRARY SCIENCE
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Filiaciones
Keywords
- Aged; Antiparkinson Agents; Carbidopa; Drug Combinations; Female; Humans; Levodopa; Male; Middle Aged; Parkinson Disease; Prospective Studies; Registries; Spain; Treatment Outcome; carbidopa; levodopa; antiparkinson agent; carbidopa; levodopa; adult; Article; brain depth stimulation; clinical article; controlled study; disease duration; electrostimulation; female; human; major clinical study; male; motor dysfunction; multicenter study; open study; Parkinson disease; parkinsonism; phenotype; Unified Parkinson Disease Rating Scale; aged; clinical trial; drug combination; drug therapy; middle aged; prospective study; register; Spain; therapy; treatment outcome
Cita
Santos D,González G,Sánchez P,Planas A,García R,Cabo I,Blázquez M,Sánchez Á,Paz JM,Cores C,Samaniego LB,Solleiro Á,Álvarez M,Freire E,Martínez JC,Pareés I,Fanjul S,Perona AB,Legarda I,Vives B,Valero MF,Cubo E,López N,Morales MI,Tabar G,Alonso D,Lorenzo JN,Rojas E,Cabo I,De Aguilar AR,Hernández J,González MV,Belmonte S,Romero JC,Escamilla F,Triguero L,Madrid CJ,Yáñez R,Ávila A,Caballol N,Peral A,Lozano D,Rábano P,Méndez A,Pérez D,Valldeoriola F,Fernández A,López E,Ribacoba C,Martínez I,MORATA C,BAVIERA R,CAMPINS M,SASTRE I,Sánchez P,Novo S,Gamo E,Martín R,Mir P,Muñoz L,Adarmes AD,Ojeda E,Jesús S,MacÍas D,Carrillo F,Castellano AM,San Eufrasio M,Pérez C,García A,Gómez C,Garrote L,Suárez San Martín E,García C,Prendes P,García Ruíz Espiga P,Feliz C,Espinosa R,Mauri L,Kulisevsky J,Pascual B,Pagonabarraga J,Campolongo A,Mata Álvarez M,Gómez JC,Fernández T,Ruiz M,Tijero B,López L,Muro I,Casas E,Lorenzo P,Gil MP,Sancho A,Quibus L,Olivares J,Rebollo B,Gómez V,Solano B,Cots A,López D,Vivas L,González J,Castaño B,Sánchez A,Escalante S,Delgado T,Cerdán DM,Mendoza A,Castrillo A,Caballero L,Gómez López De San Román C,Fernández G,Casanova J,Monterde Á,Cantarero S,Fernández B,Muñoz T,Martí G,Clavero P,Erdocia A,López AC,González AN,Guerra JD,Rashid R,Martí S,Aneiros Á,Vela L,Ruíz J,Mondragón E,Vinagre A,Gutiérrez J,López R. Device-aided therapies (DATs) in Parkinson's disease (PD). The DATs-PD GETM Spanish Registry Protocol Study. PLoS ONE. 2025. 20. e0316052. IF:2,800. (2).
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