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

Recruiting

• Conditions: Parkinson's Disease; Non-motor Symptoms

• Registration Number: NCT04366804
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-29
• Study Start: 2020-12-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NFS score	2 weeks (2 assessments in a time span of 2 weeks)
SPARK score	2 weeks (2 assessments in a time span of 2 weeks)

Trial Locations

Locations (8)

Hospital Universitario Burgos; 🇪🇸 Burgos, Spain

Centre hospitalier régional universitaire de Besançon; 🇫🇷 Besançon, France

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Transilvania University; 🇷🇴 Brasov, Romania

Ruber International Hospital; 🇪🇸 Madrid, Spain

Insel Gruppe AG University Hospital Bern; 🇨🇭 Bern, Switzerland

King's College London; 🇬🇧 London, United Kingdom