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

NCT04366804 | Recruiting

• 1 other identifier: 2020-00303
• Study Type: observational
• Target: 300
• Locations: 7 countries
• Sites: 8

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).

Conditions

Parkinson's Disease; Non-motor Symptoms

Keywords

Parkinson's Disease; Non-motor symptoms; Scales for non-motor symptoms; Validation

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Patients with neuropsychiatric fluctuations

PD patients with neuropsychiatric fluctuations (≥ 2 positive answers in QUICK test)

Patients without neuropsychiatric fluctuations

PD patients without neuropsychiatric fluctuations (≤ 1 positive answer in QUICK test)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• Carlos III Health Institute: collaborator

Study Sites (8)

Centre hospitalier régional universitaire de Besançon

Besançon, 25000, France

COMPLETED

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

COMPLETED

Aristotle University of Thessaloniki

Thessaloniki, 541 24, Greece

COMPLETED

Transilvania University

Brasov, 500036, Romania

RECRUITING

Hospital Universitario Burgos

Burgos, 09006, Spain

COMPLETED

Ruber International Hospital

Madrid, 28034, Spain

COMPLETED

Insel Gruppe AG University Hospital Bern

Bern, 3010, Switzerland

COMPLETED

King's College London

London, WC2R 2LS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Paul Krack, MD, PhD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Debove, MD

CONTACT

+41 31 63 2 79 24; ines.debove@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 29, 2020
• Study Start: December 3, 2020
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CH (1); GB (1); DE (1); GR (1); FR (1); RO (1); ES (2)