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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.