Background
Methods/design
Type of study
Specific goals
1) | To study what variables (non-motor symptoms, cognition, neuropsychiatric symptoms, falls, disability, etc.) impact negatively on both overall and health-related QoL of patients with PD. |
2) | To study what variables contribute to a worse QoL, mood and the burden of the primary caregiver for the patient with PD, as well as if the latter have repercussions on the mood and QoL of the patient him/herself. |
3) | To study the frequency of impulse control disorders and their types in patients with PD, as well as what variables are associated with them and to compare it against a control group. |
4) | To study the frequency of different non-motor symptoms in patients with PD and to compare it against a control group. |
5) | To study the frequency of pain (and its types) [90] in patients with PD, its relationship to the disease and different variables and to compare it against a control group. |
6) | |
7) | |
8) | To study the relationship between different variables (clinical, molecular, genetic and neuroimaging) and motor laterality asymmetry [95]. |
9) | To study the relationship between the serum levels of S-100b protein, TNF-ɑ, IL-1, IL-2, IL-6, vitamin B12, methylmalonic acid, homocysteine, uric acid, C-reactive protein, ferritin and iron and other disease variables in patients with PD and to compare it against a control group. |
10) | To perform genetic studies on DNA and RNA extracted from the lymphocytes of peripheral blood samples. |
11) | To study the possible value of a recently proposed imaging marker (MTAi) [30] to detect cognitive alterations in patients with PD and to compare it against a control group. |
12) | |
13) | To study the incidence of acute hospitalization throughout the 12 months following the baseline assessment (for each patient), their causes, and predictive factors in patients with PD and to compare it against a control group. |
14) | To study what percentage of patients with PD develop motor complications (in the subgroup of those who do not present them at the baseline assessment) throughout the 48 months following the baseline assessment (for each patient) and to identify predictive factors. |
15) | To study what percentage of patients with PD develop significant cognitive impairment and/or dementia over the course of the 24, 48 and 60 months following the baseline assessment (for each patient), to compare it against a control group and to identify predictive factors (clinical, molecular, genetic, imaging). |
16) | To study the morbidity and mortality of patients with PD throughout the 24 and 60 months following the baseline assessment (for each patient), to compare it against a control group and to identify predictive factors (clinical, molecular, genetic, imaging). |
17) | At the end of follow-up, to compare the course of the different clinical (motor and no-motor features) and paraclinical variables (molecular and imaging markers). |
Study population
Study design
Study assessments
Principal Investigator; PI’s participating site | City | Patients (n) | Controls (n) | Complementary studies (PDP/CS) | |
---|---|---|---|---|---|
1. | Diego Santos García; Neurology Section, Hospital Arquitecto Marcide, Complejo Hospitalario Universitario de Ferrol (CHUF). | Ferrol (A Coruña) | 60 | 10 | 45/10 |
2. | (1) Oriol de Fábregues-Boixar Nebot and (2) Jorge Hernández Vara; Movement Disorders Unit, Neurology Service, Hospital Universitario Vall d’Hebron. | Barcelona | 60 (40/20) | 20 (10/10) | 40/20 |
3. | Carmen Borrue Fernández; Movement Disorders Unit, Neurology Service, Hospital Infanta Sofía. | Madrid | 50 | 10 | NO |
4. | Pablo Mir Rivera; Movement Disorders Unit, Neurology and Clinical Neurophysiology Service, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío, CSIC and Universidad de Sevilla. | Seville | 40 | 10 | 40/0 |
5. | Maria José Martí Domenech; Parkinson’s and Movement Disorders Unit, Neurology Service, Instituto Clínico de Neurociencias, Hospital Clínic. | Barcelona | 40 | 10 | NO |
6. | Miquel Aguilar Barberá; Movement Disorders Unit, Hospital Universitario Mutua de Terrassa. | Barcelona | 40 | 10 | 30/10 |
7. | Beatriz Tijero Merino; Functional Neurology and Parkinson’s Disease Unit, Hospital de Cruces. | Bilbao | 35-40 | 10 | NO |
8. | José Chacón Peña; Neurology Unit, Hospital Infanta Luisa. | Seville | 30-35 | 10 | NO |
9. | (1) Manuel Seijo Martínez and (2) Iria Cabo López; Neurology Section, Hospital de Pontevedra. | Pontevedra | 30 (15/15) | 20 (10/10) | NO |
10. | Víctor Puente Périz; Movement Disorders Unit, Neurology Service, Hospital del Mar. | Barcelona | 25-30 | 10 | 20/10 |
11. | Inés Legarda Ramiréz; Neurology Service, Hospital Universitario Son Espases. | Palma de Mallorca | 25 | 10 | NO |
12. | Francisco Carrillo Padilla; Neurology Service, Hospital Universitario de Canarias, San Cristóbal de la Laguna. | Santa Cruz de Tenerife | 25 | 10 | 20/0 |
13. | Lydia López Manzanares; Movement Disorders Unit, Neurology Service, Hospital La Princesa. | Madrid | 25 | 10 | NO |
14. | Caridad Valero Merino; Neurology Unit, Hospital Arnau de Vilanova. | Valencia | 20-25 | 10 | NO |
15. | Jaime Kulisevsky Bojarski; Movement Disorders Unit, Neurology Service, Hospital de Sant Pau. | Barcelona | 20 | 10 | NO |
16. | José Manuel García Moreno; Movement Disorders Unit, Hospital Universitario Virgen Macarena. | Seville | 20 | 10 | 20/10 |
17. | Benito Galeano Bilbao; Neurology Section, Hospital Universitario de Ceuta. | Ceuta | 20-25 | 10 | 20/0 |
18. | Nuria Caballol Pons; Movement Disorders Unit, Consorci Sanitari Integral, Hospital Moisés Broggi. | Sant Joan Despí | 20 | 10 | NO |
19. | Mari Cruz Rodríguez Oroz; Hospital Universitario Donostia, Instituto de Investigación Biodonostia. | San Sebastián | 20 | 10 | 20/10 |
20. | María Iciar Gastón Zubimendi; Movement Disorders Unit, Neurology Service, Complejo Hospitalario de Navarra. | Pamplona | 20 | 10 | NO |
21. | Pilar Sánchez Alonso; Neurology Service, Hospital Puerta de Hierro. | Madrid | 15-25 | 10 | NO |
22. | Esther Cubo Delgado; Neurology Service, Complejo Asistencial Universitario de Burgos. | Burgos | 15 | 10 | NO |
23. | Lydia Vela Desojo; Neurology Unit, Fundación Hospital de Alcorcón. | Alcorcón (Madrid) | 15 | 10 | NO |
24. | Maria José Catalán Alonso; Movement Disorders Unit, Neurology Service, Hospital Clínico San Carlos. | Madrid | 15 | 10 | NO |
25. | Luis Manuel López Díaz; Neurology Section, Hospital de Burela. | Burela (Lugo) | 15 | 10 | NO |
26. | Maria Gema Alonso Losada; Neurology Service, Hospital Meixoeiro, Complejo Hospitalario Universitario de Vigo (CHUVI). | Vigo (Pontevedra) | 15 | 10 | NO |
27. | Nuria López Ariztegui; Movement Disorders Unit, Complejo Hospitalario de Toledo. | Toledo | 15 | 10 | NO |
28. | Mónica Kurtis Urra; Movement Disorders Unit, Neurology Service, Hospital Ruber Internacional. | Madrid | 15 | 10 | NO |
29. | Jon Infante Ceberio; Movement Disorders Unit, Neurology Service, Hospital Universitario Marqués de Valdecilla. | Santander | 15 | 10 | 15/10 |
30. | Sonia Escalante Arroyo; Neurology Service, Hospital de Tortosa Verge de la Cinta (HTVC). | Tortosa (Tarragona) | 15 | 10 | 15/10 |
31. | Juan Carlos Martínez Castrillo; Movement Disorders Unit, Neurology Service, Hospital Ramón y Cajal. | Madrid | 15 | 10 | NO |
32. | José Matías Arbelo González; Movement Disorders and Parkinson’s Disease Unit, Neurology Service, Hospital Universitario Insular de Gran Canaria. | Las Palmas de Gran Canaria | 15 | 10 | NO |
33. | René Ribacoba Montero; Movement Disorders Unit, Neurology Service, Hospital Central de Asturias. | Oviedo | 15 | 10 | 15/10 |
34. | Jessica González Ardura; Neurology Service, Hospital Universitario Lucus Augusti (HULA). | Lugo | 15 | 10 | NO |
35. | Javier López del Val; Movement Disorders Unit, Neurology Service, Hospital Clínico Universitario Lozano Blesa. | Zaragoza | 15 | 10 | NO |
36. | María Asunción Ávila Rivera; Movement Disorders Unit, Consorci Sanitari Integral, Hospital General de L’Hospitalet. | L’Hospitalet de Llobregat | 15 | 10 | NO |
37. | Hortensia Alonso Navarro; Neurology Section, Hospital Universitario del Sureste, Madrid. | Madrid | 15 | 10 | NO |
38. | Berta Solano Vila; Neurology Service, Hospital Josep Trueta and Parc Martí i Juliá, Girona. | Girona | 15 | 10 | NO |
39. | Juan García Caldentey; Neurology Unit, Hospital Quirón Palmaplanas. | Palma de Mallorca | 15 | 10 | NO |
40. | Ana Rojo Sebastián; Parkinson’s and Abnormal Movement Unit, Neurology Service, Hospital Universitario Príncipe de Asturias. | Alcalá de Henares (Madrid) | 15 | 10 | NO |
41. | Silvia Martí Martínez; Neurology Service, Hospital General de Alicante. | Alicante | 15 | 10 | NO |
42. | José Andrés Domínguez Morán; Neurology Unit, Hospital de la Rivera. | Alcira (Valencia) | 15 | 10 | NO |
43. | Irene Martínez Torres; Movement Disorders Unit, Neurology Service, Hospital La Fe. | Valencia | 15 | 10 | NO |
44. | María Álvarez Sauco; Neurology Service, Hospital General Universitario de Elche. | Elche (Alicante) | 15 | 10 | NO |
45. | Cristina Prieto Jurczynska; Movement Disorders Unit, Hospital Infanta Elena-Hospital Rey Juan Carlos-Hospital Collado Villalba, Madrid. | Madrid | 15 | 10 | NO |
1.000 | 470 | 300/100 |
Assessments | Baseline | 12 m | 24 m | 36 m | 48 m | 60 m |
---|---|---|---|---|---|---|
Inclusion/exclusion criteria | P; C | |||||
Hoehn & Yahr | P | P | P | P | P | P |
UPDRS-III and UPDRS-IV | P | P | P | P | P | P |
MMSE | P; C | P; C | P; C | P; C | ||
PD-CRS | P; C | P; C | P; C | P; C | ||
Puzzle test | P; C | P; C | P; C | P; C | ||
NMSS | P; C | P | P; C | P | P; C | P; C |
BDI-II | P; pC; C | P; pC; C | P; pC; C | P; pC; C | ||
QUIP-RS | P; C | P; C | P; C | P; C | ||
PDSS | P; C | P; C | P; C | P; C | ||
NPI | P; C | P; C | P; C | P; C | ||
VAS-Pain and VAFS | P; C | P; C | P; C | P; C | ||
FOGQ | P; C | P; C | P; C | P; C | ||
ADLS | P; C | P | P; C | P | P; C | P; C |
PDQ-39SI | P; C | P; C | P; C | P; C | ||
PQ-10 | P; pC; C | P; pC; C | P; pC; C | P; pC; C | ||
EUROHIS-QOL 8 item index | P; pC; C | P; pC; C | P; pC; C | P; pC; C | ||
ZCBI | pC | pC | pC | pC | ||
CSI | pC | pC | pC | pC | ||
Samples-serum markers | P; C | P; C | ||||
Samples-genetic studies | P; C | |||||
Head MRI | P; C | P; C |