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

November 16, 2022 updated by: University Hospital Inselspital, Berne

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

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Besançon
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus
  • Greece
      • Thessaloniki, Greece, 541 24
        • Recruiting
        • Aristotle University Of Thessaloniki
  • Romania
      • Brasov, Romania, 500036
        • Recruiting
        • Transilvania University
  • Spain
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28034
        • Recruiting
        • Ruber International Hospital
  • Switzerland
  • United Kingdom
      • London, United Kingdom, WC2R 2LS
        • Not yet recruiting
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NFS score
Time Frame: 2 weeks (2 assessments in a time span of 2 weeks)
2 weeks (2 assessments in a time span of 2 weeks)
SPARK score
Time Frame: 2 weeks (2 assessments in a time span of 2 weeks)
2 weeks (2 assessments in a time span of 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Carlos III Health Institute
Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Paul Krack, MD, PhD, Insel Gruppe AG University Hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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