Parkinson's Trial NCT04366804
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
Summary For Families
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 10 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Thinking & memory tests (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.