Validate scales measuring mood fluctuations
- Trial ID
- NCT04366804
- Official Title
- 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
- Goal
- Validate scales measuring mood fluctuations
- Status
- RECRUITING
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Study Type
- OBSERVATIONAL
- Enrollment
- 300 participants
- Conditions
- Parkinson's Disease, Non-motor Symptoms
Plain-Language Summary
The goal is to see whether two questionnaires reliably measure neuropsychiatric fluctuations and feelings of shame in people with Parkinson's, so clinicians and researchers can better track mood swings, anxiety, apathy and the social distress that often comes with the disease across countries and languages. The approach is observational, having participants complete the Neuropsychiatric Fluctuations Scale, which captures short-term changes in mood and related symptoms, and the SPARK scale, which measures shame and stigma, then testing the questionnaires for consistency, validity and cross-cultural accuracy, with no drugs or devices involved. Eligibility is adults 30 to 75 with Parkinson's by MDS criteria, fluent in the language used for the scales, able to give written consent, and without PD dementia, defined as a MoCA score below 24.
Locations
- Centre hospitalier régional universitaire de Besançon, Besançon, France
- Universitätsklinikum Carl Gustav Carus, Dresden, Germany
- Aristotle University of Thessaloniki, Thessaloniki, Greece
- Transilvania University, Brasov, Romania
- Hospital Universitario Burgos, Burgos, Spain
- Ruber International Hospital, Madrid, Spain
- Insel Gruppe AG University Hospital Bern, Bern, Switzerland
- King's College London, London, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to see whether two questionnaires reliably measure neuropsychiatric fluctuations and feelings of shame in people with Parkinson's, so clinicians and researchers can better track mood swings, anxiety, apathy and the social distress that often comes with the disease across countries and languages. The approach is observational, having participants complete the Neuropsychiatric Fluctuations Scale, which captures short-term changes in mood and related symptoms, and the SPARK scale, which measures shame and stigma, then testing the questionnaires for consistency, validity and cross-cultural accuracy, with no drugs or devices involved. Eligibility is adults 30 to 75 with Parkinson's by MDS criteria, fluent in the language used for the scales, able to give written consent, and without PD dementia, defined as a MoCA score below 24.
- Who can participate?
- Participants must be between 30 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 8 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 10 months.