International Validation of Two Non-motor Scales in PD (NFS and SPARK)

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366804
• Other study ID #: 2020-00303
• Status: Recruiting
• Start date: December 3, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: Ines Debove, MD
• Phone: +41 31 63 2 79 24
• Email: ines.debove[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Non-motor Symptoms
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
France	Centre hospitalier régional universitaire de Besançon	Besançon
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Greece	Aristotle University of Thessaloniki	Thessaloniki
Romania	Transilvania University	Brasov
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Ruber International Hospital	Madrid
Switzerland	Insel Gruppe AG University Hospital Bern	Bern
United Kingdom	King's College London	London

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Carlos III Health Institute, Michael J. Fox Foundation for Parkinson's Research

Countries where clinical trial is conducted

France,  Germany,  Greece,  Romania,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NFS score		2 weeks (2 assessments in a time span of 2 weeks)
Primary	SPARK score		2 weeks (2 assessments in a time span of 2 weeks)