Parkinson's DiseaseNoMoFANCT06406374
Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire: an Observational, Multicentric, Cross-sectional, 6-months Duration Study on 200 Consecutive Parkinson's Disease Patients.
An observational study of Parkinson's Disease, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
Parkinson's disease (PD) has been traditionally considered a movement disorder. In fact, it is now recognized as a multisystemic disease involving not only the central nervous system and presenting with a constellation of motor and non-motor features. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2023to 10 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will enroll 200 consecutive patients with a diagnosis of idiopathic Parkinson\'s disease according to validated clinical criteria and experiencing symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2.
Who may be able to join
- Diagnosis of idiopathic Parkinson\'s disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015);
- Italian speaker;
- Mini-mental state examinations (MMSE) score \>25;
- Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2;
- Stable antiparkinsonian medications for at least three months
- Ability to provide informed consent.
Who cannot join
- Atypical Parkinsonian syndrome
- H\&Y\>4
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di Neuroscienze e Salute Mentale SC Neurologia 2U
Torino, TO, 10126
Carlo Alberto Artusi, MD, PhD, 011 6709366, carloalberto.artusi@unito.it
About this study
Official title: Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire.
Parkinson's disease (PD) has been traditionally considered a movement disorder. In fact, it is now recognized as a multisystemic disease involving not only the central nervous system and presenting with a constellation of motor and non-motor features. While the dopaminergic therapy used to control motor symptoms can lead to the development of motor fluctuations, characterized by wearing-off, ON-OFF phenomenon, delayed-ON, dose failure, and dyskinesias, it has been demonstrated that also many non-motor symptoms can have daily fluctuations, according to the response to dopaminergic therapy. Therefore, non-motor symptoms may fluctuate in parallel with motor symptoms and their relationship to plasma dopamine concentration, although the exact mechanism of non-motor fluctuations (NMF) remains speculative. Non-motor features tend to worsen during disease progression and prove to severely impact the quality of life of patients, sometimes more than motor symptoms. The Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire is a patient-derived and self-administered questionnaire, recently developed and validated by the International Parkinson and Movement Disorder Society (MDS), that identifies and quantifies the severity of static and fluctuating non-motor symptoms in people with PD. The NoMoFA scale is constituted of a total of 27 items investigating several non-motor features, such as fatigue (the most reported), sleepiness, and confusion. Considering the self-administered nature of the scale, patients must understand the questions, and it should be available in the patient\'s native language. However, the NoMoFa has not yet been translated into the Italian language. Considering that NoMoFA is a relevant scale in the assessment of patients with PD, we believe it is important to perform a translation and cross-cultural adaptation of the NoMoFA questionnaire in Italian, following the scales translation protocol from the international movement disorders society (MDS), and to analyze the reliability and construct validity of the translated scale in Italian patients with PD who experience non-motor fluctuations. The aim of the study is to translate and validate the adapted Italian version of NoMoFA questionnaire.
Read the detailed description
This is a multicenter, cross-sectional study involving 200 consecutive patients with a diagnosis of idiopathic PD.
We will collect demographic data such as age, sex and education, and clinical features encompassing age at onset, disease duration, antiparkinsonian treatment, and levodopa-equivalent daily dose (LEDD). Patients will undergo a clinical examination in which we will record the Hoehn and Yahr scale (H\&Y) and Movement Disorders Unified Parkinson\'s Disease Rating Scale (MDS-UPDRS) part I-II- III (in ON state) and IV, and Montreal Cognitive Assessment (MoCA). The answers to the NoMoFA will be obtained giving the self-administered questionnaire to patients during regular follow-up visits. The NoMoFA Questionnaire has a total of 27 items with a total maximum possible score for the NoMoFA of 81 points (27 x 3). To evaluate the stability of the Italian version of the NoMoFA (test-retest reliability), a group of 60 patients will repeat the scale 14 days after the first evaluation.
We will establish a translation team composed of movement disorders specialists who are native speakers of the designated language and fluent in English. As word-for-word translations can be misleading, cultural difference between English and Italian will be taken into account. After translation, a different independent group with same competencies of the first translating team will perform a back-translation. The back-translated version of the rating scale will be compared to the original English version. The translation and back-translation team members in a revised document will fully resolve unclear concepts or ambiguities between the original and back-translated English editions. Before the validation phase, a so-called 'cognitive pretesting' will be performed by submitting the provisional translated scale to 10 PD patients by 2 evaluators external to the translator team. Then, evaluators\' and subjects\' responses will be integrated into the revisions and retested until all major problems are resolved. Once the translation and cognitive pretesting stages are completed, the translated scale is field-tested in a sample of native speakers of the language of the translated scale (validation).
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Non-motor fluctuations, NoMoFA
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Patients will present the following inclusion criteria: * Diagnosis of idiopathic Parkinson's disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015); * Italian speaker; * Mini-mental state examinations (MMSE) score >25; * Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score>=2; * Stable antiparkinsonian medications for at least three months; * Ability to provide informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-motor fluctuations assessment
The aim of this study is to validate an Italian version of NoMoFA scale for the evaluation of non-motor symptoms fluctuations.
Measured: The entire project is planned for a duration of 13 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start26 Apr 2023
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Alberto Artusi, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406374
- Sponsor's protocol ID
- 0068862
- Acronym
- NoMoFA
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kleiner G, Fernandez HH, Chou KL, Fasano A, Duque KR, Hengartner D, Law A, Margolius A, Poon YY, Saenz Farret M, Saleh P, Vizcarra JA, Stebbins GT, Espay AJ; PSG NoMoFA Study Group. Non-Motor Fluctuations in Parkinson's Disease: Validation of the Non-Motor Fluctuation Assessment Questionnaire. Mov Disord. 2021 Jun;36(6):1392-1400. doi: 10.1002/mds.28507. Epub 2021 Feb 15.
PubMed 33590555
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire.
- ClinicalTrials.gov ID
- NCT06406374
- Acronym / sponsor ID
- NoMoFA / 0068862
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Non-motor fluctuations, NoMoFA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 9 May 2024 (actual)
- 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.
Parkinson's disease (PD) has been traditionally considered a movement disorder. In fact, it is now recognized as a multisystemic disease involving not only the central nervous system and presenting with a constellation of motor and non-motor features. While the dopaminergic therapy used to control motor symptoms can lead to the development of motor fluctuations, characterized by wearing-off, ON-OFF phenomenon, delayed-ON, dose failure, and dyskinesias, it has been demonstrated that also many non-motor symptoms can have daily fluctuations, according to the response to dopaminergic therapy. Therefore, non-motor symptoms may fluctuate in parallel with motor symptoms and their relationship to plasma dopamine concentration, although the exact mechanism of non-motor fluctuations (NMF) remains speculative. Non-motor features tend to worsen during disease progression and prove to severely impact the quality of life of patients, sometimes more than motor symptoms. The Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire is a patient-derived and self-administered questionnaire, recently developed and validated by the International Parkinson and Movement Disorder Society (MDS), that identifies and quantifies the severity of static and fluctuating non-motor symptoms in people with PD. The NoMoFA scale is constituted of a total of 27 items investigating several non-motor features, such as fatigue (the most reported), sleepiness, and confusion. Considering the self-administered nature of the scale, patients must understand the questions, and it should be available in the patient\'s native language. However, the NoMoFa has not yet been translated into the Italian language. Considering that NoMoFA is a relevant scale in the assessment of patients with PD, we believe it is important to perform a translation and cross-cultural adaptation of the NoMoFA questionnaire in Italian, following the scales translation protocol from the international movement disorders society (MDS), and to analyze the reliability and construct validity of the translated scale in Italian patients with PD who experience non-motor fluctuations. The aim of the study is to translate and validate the adapted Italian version of NoMoFA questionnaire.
Detailed description
This is a multicenter, cross-sectional study involving 200 consecutive patients with a diagnosis of idiopathic PD.
We will collect demographic data such as age, sex and education, and clinical features encompassing age at onset, disease duration, antiparkinsonian treatment, and levodopa-equivalent daily dose (LEDD). Patients will undergo a clinical examination in which we will record the Hoehn and Yahr scale (H\&Y) and Movement Disorders Unified Parkinson\'s Disease Rating Scale (MDS-UPDRS) part I-II- III (in ON state) and IV, and Montreal Cognitive Assessment (MoCA). The answers to the NoMoFA will be obtained giving the self-administered questionnaire to patients during regular follow-up visits. The NoMoFA Questionnaire has a total of 27 items with a total maximum possible score for the NoMoFA of 81 points (27 x 3). To evaluate the stability of the Italian version of the NoMoFA (test-retest reliability), a group of 60 patients will repeat the scale 14 days after the first evaluation.
We will establish a translation team composed of movement disorders specialists who are native speakers of the designated language and fluent in English. As word-for-word translations can be misleading, cultural difference between English and Italian will be taken into account. After translation, a different independent group with same competencies of the first translating team will perform a back-translation. The back-translated version of the rating scale will be compared to the original English version. The translation and back-translation team members in a revised document will fully resolve unclear concepts or ambiguities between the original and back-translated English editions. Before the validation phase, a so-called 'cognitive pretesting' will be performed by submitting the provisional translated scale to 10 PD patients by 2 evaluators external to the translator team. Then, evaluators\' and subjects\' responses will be integrated into the revisions and retested until all major problems are resolved. Once the translation and cognitive pretesting stages are completed, the translated scale is field-tested in a sample of native speakers of the language of the translated scale (validation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | –Patients will present the following inclusion criteria: * Diagnosis of idiopathic Parkinson's disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015); * Italian speaker; * Mini-mental state examinations (MMSE) score >25; * Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score>=2; * Stable antiparkinsonian medications for at least three months; * Ability to provide informed consent. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will enroll 200 consecutive patients with a diagnosis of idiopathic Parkinson\'s disease according to validated clinical criteria and experiencing symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2.
Key inclusion criteria (6 listed)
- Diagnosis of idiopathic Parkinson\'s disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015);
- Italian speaker;
- Mini-mental state examinations (MMSE) score \>25;
- Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2;
- Stable antiparkinsonian medications for at least three months
Key exclusion criteria (3 listed)
- Atypical Parkinsonian syndrome
- H\&Y\>4
- Patients under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-motor fluctuations assessment
Time frame: The entire project is planned for a duration of 13 months.
The aim of this study is to validate an Italian version of NoMoFA scale for the evaluation of non-motor symptoms fluctuations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 33590555Kleiner G, Fernandez HH, Chou KL, Fasano A, Duque KR, Hengartner D, Law A, Margolius A, Poon YY, Saenz Farret M, Saleh P, Vizcarra JA, Stebbins GT, Espay AJ; PSG NoMoFA Study Group. Non-Motor Fluctuations in Parkinson's Disease: Validation of the Non-Motor Fluctuation Assessment Questionnaire. Mov Disord. 2021 Jun;36(6):1392-1400. doi: 10.1002/mds.28507. Epub 2021 Feb 15.
- Individual participant dataSharing planned: Undecided
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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.
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 A.O.U. Città della Salute e della Scienza 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 6 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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 Carlo Alberto Artusi, MD, PhD (+390116709366, carloalberto.artusi@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-motor fluctuations assessment (time frame: The entire project is planned for a duration of 13 months.). 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 NCT06406374, which also lists 1 linked publication.
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 9 May 2024.