Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale (IRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092936
Recruitment Status : Unknown
Verified March 2010 by Fondazione Neureca.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2010
Last Update Posted : March 25, 2010
Information provided by:
Fondazione Neureca

Brief Summary:

The present study is part of an international program and deals with the translation and validation program for the Italian version of the MDS-UPDRS.

The program will be articulated in three steps:

  • Phase I: translation and back-translation of the MDS-UPDRS in Italian (completed)
  • Phase II: Cognitive testing. This step is aimed at a preliminary testing of a subset of potentially culturally sensitive items in a limited set of PD patients (approximately 10). Should this phase identify issues in the understanding and ease of use of some items a revised translation of some individual items might be envisaged.
  • Phase III: large validation testing: this phase will involve 350 PD patients from 12-14 Italian PD centres.

The IRIS protocol deals with phase II and III of the program.

Condition or disease Intervention/treatment
Parkinson's Disease Other: Rating Scale administration

Study Type : Observational
Estimated Enrollment : 350 participants
Time Perspective: Prospective
Official Title: Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale
Study Start Date : March 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: Rating Scale administration
    Movement Disorder Society_Unified Parkinson's Disease Rating Scale will be submitted to the patient (with the help of the caregiver) in a single visit lasting about 40 minutes.

Primary Outcome Measures :
  1. Phase II: To test the appropriateness of the Italian translation and clear understanding of potentially cultural-sensitive items. To refine the translation, if necessary, prior to validation testing. [ Time Frame: 6 months ]
  2. Phase III: the primary outcome of phase III is to confirm factorial analysis of the Italian version against the factor structure of the English version, by each of the four sections of the scale. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The secondary outcome is to determine the Differential Item Function (DIF) which will be run on items by gender, race , disease severity, education and age. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Native Italian-speaking PD patients ranging from mild to severe

Inclusion Criteria:

  • Written and signed informed consent;
  • native Italian-speaking patients or either sex;
  • patients suffering from Parkinson's disease ranging from mild to severe, based on clinical judgement;
  • presence of a native Italian-speaking caregiver.

Exclusion Criteria:

  • Patients with evidence of other central nervous system disorders;
  • patients with a degree of depression or dementia which may prevent and/or affect ratings.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01092936

Contact: Silvia Campanella, Dr +39 02 34535088 ext 31
Contact: M.Cristina Jori, Dr. +39 02 34535088 ext 23

Universita' Federico II di Napoli Not yet recruiting
Napoli, Italy, 80131
Contact: Paolo Barone, Prof.    +39 081 7462670   
Principal Investigator: Paolo Barone, Prof.         
Sponsors and Collaborators
Fondazione Neureca
Principal Investigator: Paolo Barone, Prof. Universita' Federico II di Napoli
Principal Investigator: Maurizio Zibetti, Dr Azienda Sanitaria Ospedaliera "San Giovanni Battista di Torino" Le Molinette
Principal Investigator: Angelo Antonini, Prof Ospedale San Camillo IRCCS Venezia
Principal Investigator: Gianni Pezzoli, Prof Istituti Clinici di Perfezionamento Milano
Principal Investigator: Michele Tinazzi, Prof Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.Rossi
Principal Investigator: Giovanni Abbruzzese, Prof Universita' di Genova
Principal Investigator: Ubaldo Bonuccelli, Prof Universita' di Pisa
Principal Investigator: Giovanni Fabbrini, Dr Universita' La Sapienza di Roma
Principal Investigator: Letterio Morgante, Prof Azienda Ospedaliera Universitaria Policlinico G.Martino di Messina
Principal Investigator: Mario Zappia, Prof Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele di Catania
Principal Investigator: Alberto Albanese, Prof Istituto Neurologico "Carlo Besta" di Milano
Principal Investigator: Claudio Pacchetti Istituto Neurologico Nazionale Fondazione IRCCS "C. Mondino" di Pavia
Principal Investigator: Aldo Quattrone, Prof Policlinico Universitario Mater Domini di Catanzaro
Principal Investigator: Giovanni Cossu, Dr Azienda Ospedaliera "G. Brotzu" di Cagliari
Principal Investigator: Aroldo Rossi, Prof Universita' degli Studi di Perugia
Principal Investigator: Paolo Martinelli, Prof Universita' di Bologna

Additional Information:
S. Fahn et al: The Unified Rating Scale for Parkinsonism. In Fahn, Marsden, Jenner, Teychenne eds.: Recent Developments in Parkinson's disease. N.J. Macmillan Healthcare Information: 153-63, 1987

Responsible Party: Dr. Linda Toscano, Fondazione NEURECA Identifier: NCT01092936     History of Changes
Other Study ID Numbers: IRIS
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: March 2010

Keywords provided by Fondazione Neureca:
Comparative fit index
Movement Disorders' Society
Unified Parkinson's Disease Rating Scale

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases