Clinical trial NCT04366804: International Validation of Two Non-motor Scales in PD (NFS and SPARK)
Official title: International Validation of Two Non-motor Scales in Parkinson's Disease: the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in Parkinson's Disease (SPARK) Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease
Non-motor Symptoms
Keywords: Parkinson's Disease
Non-motor symptoms
Scales for non-motor symptoms
Validation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: Carlos III Health Institute
First posted: 2020-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The project population consists of PD patients with and without neuropsychiatric fluctuations attending routine visits to movement disorders clinics in the participant countries. Only patients capable of giving informed consent will be considered for participation in this project.

Brief summary: The goal of this project is to develop the international validation of two new rating scales, the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale, in order to improve the understanding of the extent and severity of non-motor symptoms in Parkinson's disease (PD).

Detailed description: This project is a prospective international multicentre study to validate two new rating scales in different languages: the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale.

The project population consists a minimum of 300 PD patients with and without fluctuations in the participant countries: Spain, Germany, France, Switzerland, Romania and Greece.

The NFS is specifically designed to detect neuropsychiatric fluctuations between off- and on-medication condition in PD. It is composed of 20 items, 10 items measuring the on-neuropsychological symptoms and 10 items for the off-neuropsychological manifestations. The validation of this scale, based on the most frequently experienced symptoms by the patients, would allow a crucial breakthrough in the improvement of management of PD patients.

Shame and embarrassment are poorly recognized by physicians in PD. PD-related shame and embarrassment may emerge from motor and non-motor symptoms, from self-perception of inadequacy due to loss of autonomy and need for help, or from perceived deterioration of body image. The current available scales are not specific for PD. Based on reports of persons affected with PD and a literature review about shame and stigmatization in PD a 25-items self-questionnaire for shame and embarrassment in PD was created. The scale includes 6 different subscales (1. Shame arising from PD symptoms; 2. Shame arising from the increasing physical dependence and need for help induced by PD; 3. Shame arising from the patient's assumption of breaking certain social rules; 4. Shame arising from the deteriorated body image; 5. Consequence of related shame and embarrassment on patients' health-related quality of life; 6. Stigmatization). The validation of this scale will give a tool for physicians and researchers to better understand the impact of PD on patient's quality of life.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent;
2. PD, according to the MDS criteria;
3. Age of participants \> 30 and \< 75 years;
4. Being fluent in the language in which the scales are applied.

Exclusion Criteria:

1. Presence of PD dementia (defined as MoCA score \< 24).

Primary outcomes:
measure: NFS score
timeFrame: 2 weeks (2 assessments in a time span of 2 weeks)
measure: SPARK score
timeFrame: 2 weeks (2 assessments in a time span of 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre hospitalier régional universitaire de Besançon
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
city: Brasov
country: Romania
facility: Transilvania University
city: Burgos
country: Spain
facility: Hospital Universitario Burgos
city: Madrid
country: Spain
facility: Ruber International Hospital
city: Bern
country: Switzerland
facility: Insel Gruppe AG University Hospital Bern
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Paul Krack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: