Validation of new scales for non-motor symptoms in Parkinson's Disease
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
This study is testing two new tools to help understand and measure non-motor symptoms like mood changes and feelings of shame in people with Parkinson's Disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 8 sites (Besançon and 7 other locations) |
| Trial ID | NCT04366804 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 30 to 75 who have been diagnosed with Parkinson's Disease and can provide informed consent.
Not a fit: Patients with Parkinson's Disease dementia or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recognition and management of non-motor symptoms in Parkinson's Disease, enhancing patient care.
How similar studies have performed: Other studies have shown success in validating scales for non-motor symptoms in various conditions, but the specific scales being validated in this study are novel for Parkinson's Disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Besançon and 7 other locations
- Centre hospitalier régional universitaire de Besançon — Besançon, France (Completed)
- Universitätsklinikum Carl Gustav Carus — Dresden, Germany (Completed)
- Aristotle University of Thessaloniki — Thessaloniki, Greece (Completed)
- Transilvania University — Brasov, Romania (Recruiting)
- Hospital Universitario Burgos — Burgos, Spain (Completed)
- Ruber International Hospital — Madrid, Spain (Completed)
- Insel Gruppe AG University Hospital Bern — Bern, Switzerland (Completed)
- King's College London — London, United Kingdom (Recruiting)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.