AzTrials
AzTrials

PARKINSON DISEASE (Disorder)GIDS-PD_ITANCT07316751

Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease

An observational study of PARKINSON DISEASE (Disorder) and Parkinson Disease, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 5 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to translate and validate the Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) into Italian to enable the assessment of gastrointestinal symptoms in Italian-speaking patients with Parkinson's disease. Read more about this study

Who is it for?
Ages 18 years and older
How many people
190 participants
Where
5 sitesItaly
Study dates
8 Oct 2025to Nov 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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: The study population will include patients with PD attending the movement disorders Units of the study centres.

Who may be able to join

  • Age ≥18 years;
  • Diagnosis of PD according to the Movement Disorder Society (MDS) diagnostic criteria (Postuma RB et al., 2015);
  • Italian-native patients or patients that understand Italian correctly at least;
  • Participants mentally and physically able to understand and sign the informed consent form.

Who cannot join

  • Persons in the terminal phase of disease;
  • Persons with clinically relevant cognitive impairment;
  • Persons diagnosed with Parkinsonism other than PD.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

Italy5 sites, 5 recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

    Roberto Eleopra, MD, + 39 02.2394, maria.gammone@istituto-besta.it

    Recruiting

  • Ospedale Universitario Luigi Sacco, Milano, Italia

    Milan

    Leonardo Pantoni, MD, + 39 02.2394, leonardo.pantoni@unimi.it

    Not yet recruiting

  • Unità Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze(DNS), Università di Padova, Padova, Italia

    Padova

    Angelo Antonini, angelo.antonini@unipd.it

    Not yet recruiting

  • Centro per le Malattie Neurodegenerative e l'Invecchiamento Cerebrale, Università degli Studi di Bari "Aldo Moro" presso la Pia Fondazione "Card. G. Panico", Tricase, Italia

    Tricase

    Daniele Urso, MD, + 39 02.2394, daniele.urso@kcl.ac.uk

    Not yet recruiting

  • Unità di Neurologia, Divisione Malattia di Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze, Biomedicina e Scienze del Movimento, Università di Verona, Italia

    Verona

    Michele Tinazzi, MD, michele.tinazzi@univr.it

    Not yet recruiting

Other trials in Italy

About this study

This study aims to translate and validate the Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) into Italian to enable the assessment of gastrointestinal symptoms in Italian-speaking patients with Parkinson's disease. The psychometric properties of the translated instrument will be evaluated through a multi-phase process involving translation/back-translation, pre-testing, and large-scale validation across multiple Italian centers

Read the detailed description

Gastrointestinal dysfunction is a frequent and burdensome non-motor feature of Parkinson's disease, yet validated tools to measure these symptoms are not available for Italian-speaking patients. The study will will undergo three distinct phases, as specified by the MDS guidelines (International Parkinson and Movement Disorder Society, 2023): translation and back-translation (Phase I), pre-test (Phase II), large-scale validation test (Phase III).

  • Phase I The translation and back-translation process will be conducted by two independent teams; one team will translate the content from English to Italian, followed by another team independently back-translating it from Italian to English (back-translation).
  • Phase II Phase II will involve about 10 PD patients, as heterogeneous as possible, from different Italian regions, and 10 clinicians (PD nurses, neurologists, etc) examiners. The instrument, in this preliminary version, will be presented to a group of about 10 PD patients for the pre-test phase. This phase will be used to establish the basic psychometric properties of the scale and identify items that could potentially be culturally complex.
  • Phase III Once the official translation has been approved, the instrument will be administered to a sample of PD patients, native Italian speakers, heterogeneous as far as possible in age and gender.

The final Italian version will be assessed for data quality, acceptability, construct validity, and reliability in a cohort of patients diagnosed with Parkinson's disease across multiple Italian centers.

Keywords
Parkinson's Disease, Gastrointestinal Dysfunction, Scale Validation
Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Translation the Italian version of GIDS-PD

    Score on the Italian version of the Geriatric Impulse Dyscontrol Scale-Parkinson's Disease (GIDS-PD), total score ranging from 0 to 100, with higher scores indicating greater impulse control difficulties.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start8 Oct 2025
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07316751
Sponsor's protocol ID
GIDS-PD_ITA
Acronym
GIDS-PD_ITA
Status last verified
Nov 2025
First submitted
24 Nov 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.

    PubMed 17161752

  • Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.

    PubMed 26474316

  • Leta V, Klingelhoefer L, Longardner K, Campagnolo M, Levent HC, Aureli F, Metta V, Bhidayasiri R, Chung-Faye G, Falup-Pecurariu C, Stocchi F, Jenner P, Warnecke T, Ray Chaudhuri K; International Parkinson and Movement Disorders Society Non-Motor Parkinson's Disease Study Group. Gastrointestinal barriers to levodopa transport and absorption in Parkinson's disease. Eur J Neurol. 2023 May;30(5):1465-1480. doi: 10.1111/ene.15734. Epub 2023 Mar 7.

    PubMed 36757008

  • Metta V, Leta V, Mrudula KR, Prashanth LK, Goyal V, Borgohain R, Chung-Faye G, Chaudhuri KR. Gastrointestinal dysfunction in Parkinson's disease: molecular pathology and implications of gut microbiome, probiotics, and fecal microbiota transplantation. J Neurol. 2022 Mar;269(3):1154-1163. doi: 10.1007/s00415-021-10567-w. Epub 2021 Apr 21.

    PubMed 33881598

  • Maxwell SE, Kelley K, Rausch JR. Sample size planning for statistical power and accuracy in parameter estimation. Annu Rev Psychol. 2008;59:537-63. doi: 10.1146/annurev.psych.59.103006.093735.

    PubMed 17937603

  • Camacho M, Greenland JC, Williams-Gray CH. The Gastrointestinal Dysfunction Scale for Parkinson's Disease. Mov Disord. 2021 Oct;36(10):2358-2366. doi: 10.1002/mds.28675. Epub 2021 Jun 16.

    PubMed 34133059

  • Bhidayasiri R, Phuenpathom W, Tan AH, Leta V, Phumphid S, Chaudhuri KR, Pal PK. Management of dysphagia and gastroparesis in Parkinson's disease in real-world clinical practice - Balancing pharmacological and non-pharmacological approaches. Front Aging Neurosci. 2022 Aug 11;14:979826. doi: 10.3389/fnagi.2022.979826. eCollection 2022.

    PubMed 36034128

Questions about this trial

What is this clinical trial studying?

An observational study of PARKINSON DISEASE (Disorder) and Parkinson Disease, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 5 sites 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 3 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Translation the Italian version of GIDS-PD (time frame: 3 years). 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 NCT07316751, which also lists 7 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 11 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in