Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire.

Status: Recruiting
Location: See location...
Study Type: Observational
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. 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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Dipartimento di Neuroscienze e Salute Mentale SC Neurologia 2U
RECRUITING
Torino
Contact Information
Primary
Carlo Alberto Artusi, MD, PhD
carloalberto.artusi@unito.it
+390116709366
Time Frame
Start Date: 2023-04-26
Estimated Completion Date: 2024-06-10
Participants
Target number of participants: 200
Treatments
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.
Sponsors
Leads: A.O.U. Città della Salute e della Scienza

This content was sourced from clinicaltrials.gov