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RecruitingNCT07316751GIDS-PD_ITAUpdated Feb 11, 2026

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

An observational study in PARKINSON DISEASE (Disorder) and Parkinson Disease, sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. Recruiting at 5 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
190
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • PARKINSON DISEASE (Disorder)
  • Parkinson Disease

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Keywords

  • Parkinson's Disease
  • Gastrointestinal Dysfunction
  • Scale Validation
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 190 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta is the lead sponsor of 83 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Other
Enrollment
190 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  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.

    Time frame: 3 years

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Study locations

1 of 5 sites recruiting
  • Fondazione IRCCS Istituto Neurologico Carlo Besta
    Milan, 20133, Italy
    Recruiting
  • Ospedale Universitario Luigi Sacco, Milano, Italia
    Milan, Italy
    Not yet recruiting
  • Unità Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze(DNS), Università di Padova, Padova, Italia
    Padova, Italy
    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, Italy
    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, Italy
    Not yet recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07316751
Lead sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Responsible party
Sponsor
First posted
Jan 5, 2026
Start date
Oct 8, 2025
Primary completion
Nov 2028 (estimated)
Completion
Nov 2028 (estimated)
Last update
Feb 11, 2026

Study contacts

Roberto Eleopra, MD
principal investigator · Fondazione IRCCS Istituto Neurologico Carlo Besta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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