Validation of new scales for non-motor symptoms in Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to validate two new rating scales, the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale, to better understand non-motor symptoms in Parkinson's Disease (PD). It is a prospective international multicentre study involving at least 300 PD patients across several countries including Spain, Germany, France, Switzerland, Romania, and Greece. The NFS focuses on detecting neuropsychiatric fluctuations in patients, while the SPARK Scale addresses issues of shame and embarrassment related to PD. The validation of these scales is expected to enhance the management of PD by providing more accurate assessments of these symptoms.

Why it matters

Who can join: the full rules

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).

Where it's running

• Transilvania University
  Brasov, Romania Recruiting
• King's College London
  London, United Kingdom Recruiting
• Centre hospitalier régional universitaire de Besançon
  Besançon, France Completed
• Universitätsklinikum Carl Gustav Carus
  Dresden, Germany Completed
• Aristotle University of Thessaloniki
  Thessaloniki, Greece Completed
• Hospital Universitario Burgos
  Burgos, Spain Completed

Study contacts

• Principal investigator: Paul Krack, MD, PhD — Insel Gruppe AG, University Hospital Bern
• Study coordinator: Ines Debove, MD
• Email: ines.debove@insel.ch
• Phone: +41 31 63 2 79 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.