Parkinson's DiseaseIRISNCT01092936
Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale
An observational study of Parkinson's Disease, run by Fondazione Neureca at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rating Scale administration
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Native Italian-speaking PD patients ranging from mild to severe
Who may be able to join
- 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.
Who cannot join
- Patients with evidence of other central nervous system disorders;
- patients with a degree of depression or dementia which may prevent and/or affect ratings.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Universita' Federico II di Napoli
Naples, 80131
Paolo Barone, Prof., +39 081 7462670, barone@unina.it
Paolo Barone, Prof.
About this study
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:
Read more
- 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.
- Conditions
- Parkinson's Disease
- Being tested
- Rating Scale administration
- Keywords
- Comparative fit index, Movement Disorders' Society, Unified Parkinson's Disease Rating Scale
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rating Scale administrationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Neureca
- Sponsor type
- University, hospital or other
- Investigators
- Paolo Barone, Prof., Principal investigator, Universita' Federico II di NapoliMaurizio Zibetti, Dr, Principal investigator, Azienda Sanitaria Ospedaliera "San Giovanni Battista di Torino" Le MolinetteAngelo Antonini, Prof, Principal investigator, Ospedale San Camillo IRCCS VeneziaGianni Pezzoli, Prof, Principal investigator, Istituti Clinici di Perfezionamento MilanoMichele Tinazzi, Prof, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.RossiGiovanni Abbruzzese, Prof, Principal investigator, Universita' di GenovaUbaldo Bonuccelli, Prof, Principal investigator, Universita' di PisaGiovanni Fabbrini, Dr, Principal investigator, Universita' La Sapienza di Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092936
- Sponsor's protocol ID
- IRIS
- Acronym
- IRIS
- Status last verified
- Mar 2010
- First submitted
- 24 Mar 2010
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. doi: 10.1002/mds.10473.
PubMed 12815652Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. doi: 10.1002/mds.21198.
PubMed 17115387Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
PubMed 19025984Pagonabarraga J, Kulisevsky J, Llebaria G, Garcia-Sanchez C, Pascual-Sedano B, Gironell A. Parkinson's disease-cognitive rating scale: a new cognitive scale specific for Parkinson's disease. Mov Disord. 2008 May 15;23(7):998-1005. doi: 10.1002/mds.22007.
PubMed 18381647
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale
- ClinicalTrials.gov ID
- NCT01092936
- Acronym / sponsor ID
- IRIS / IRIS
- Conditions
- Parkinson's Disease
- Keywords
- Comparative fit index, Movement Disorders' Society, Unified Parkinson's Disease Rating Scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Fondazione NeurecaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Native Italian-speaking PD patients ranging from mild to severe
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with evidence of other central nervous system disorders;
- patients with a degree of depression or dementia which may prevent and/or affect ratings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rating Scale administrationMovement 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. | Other | – |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
- BackgroundS. 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
- Background: PubMed 12815652Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. doi: 10.1002/mds.10473.
- Background: PubMed 17115387Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. doi: 10.1002/mds.21198.
- Background: PubMed 19025984Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
- Background: PubMed 18381647Pagonabarraga J, Kulisevsky J, Llebaria G, Garcia-Sanchez C, Pascual-Sedano B, Gironell A. Parkinson's disease-cognitive rating scale: a new cognitive scale specific for Parkinson's disease. Mov Disord. 2008 May 15;23(7):998-1005. doi: 10.1002/mds.22007.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Barone, Prof. principal investigator
Universita' Federico II di Napoli
Maurizio Zibetti, Dr principal investigator
Azienda Sanitaria Ospedaliera "San Giovanni Battista di Torino" Le Molinette
Angelo Antonini, Prof principal investigator
Ospedale San Camillo IRCCS Venezia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Fondazione Neureca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Campanella, Dr (+39 02 34535088 ext. 31, campanella@mcr-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092936, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2010.