NCT04366804 International Validation of Two Non-motor Scales in PD (NFS and SPARK)
| NCT ID | NCT04366804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Parkinson's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-12-03 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-12-03 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this project is to develop the international validation of two new rating scales, the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale, in order to improve the understanding of the extent and severity of non-motor symptoms in Parkinson's disease (PD).
Eligibility 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).
Contact & Investigator
Paul Krack, MD, PhD
PRINCIPAL INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT04366804 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04366804 currently recruiting?
Yes, NCT04366804 is actively recruiting participants. Contact the research team at ines.debove@insel.ch for enrollment information.
Where is the NCT04366804 trial being conducted?
This trial is being conducted at Besançon, France, Dresden, Germany, Thessaloniki, Greece, Brasov, Romania and 4 additional locations.
Who is sponsoring the NCT04366804 clinical trial?
NCT04366804 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Paul Krack, MD, PhD at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 300 participants.
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