Parkinson's DiseaseNCT04366804
International Validation of Two Non-motor Scales in PD (NFS and SPARK)
An observational study of Parkinson's Disease and Non-motor Symptoms, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease, Non-motor Symptoms
- How many people
- 300 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 3 Dec 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The project population consists of PD patients with and without neuropsychiatric fluctuations attending routine visits to movement disorders clinics in the participant countries. Only patients capable of giving informed consent will be considered for participation in this project.
Who may be able to join
- Written informed consent;
- PD, according to the MDS criteria;
- Age of participants > 30 and < 75 years;
- Being fluent in the language in which the scales are applied.
Who cannot join
- 1. Presence of PD dementia (defined as MoCA score < 24).
Trial locations and contacts
8 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 7 countries
Spain2 sites
- Completed
Hospital Universitario Burgos
Burgos, 09006
- Completed
Ruber International Hospital
Madrid, 28034
France1 site
- Completed
Centre hospitalier régional universitaire de Besançon
Besançon, 25000
Greece1 site
- Completed
Aristotle University of Thessaloniki
Thessaloniki, 541 24
Switzerland1 site
- Completed
Insel Gruppe AG University Hospital Bern
Bern, 3010
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, WC2R 2LS
About this study
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
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).
Read the detailed description
This project is a prospective international multicentre study to validate two new rating scales in different languages: the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale.
The project population consists a minimum of 300 PD patients with and without fluctuations in the participant countries: Spain, Germany, France, Switzerland, Romania and Greece.
The NFS is specifically designed to detect neuropsychiatric fluctuations between off- and on-medication condition in PD. It is composed of 20 items, 10 items measuring the on-neuropsychological symptoms and 10 items for the off-neuropsychological manifestations. The validation of this scale, based on the most frequently experienced symptoms by the patients, would allow a crucial breakthrough in the improvement of management of PD patients.
Shame and embarrassment are poorly recognized by physicians in PD. PD-related shame and embarrassment may emerge from motor and non-motor symptoms, from self-perception of inadequacy due to loss of autonomy and need for help, or from perceived deterioration of body image. The current available scales are not specific for PD. Based on reports of persons affected with PD and a literature review about shame and stigmatization in PD a 25-items self-questionnaire for shame and embarrassment in PD was created. The scale includes 6 different subscales (1. Shame arising from PD symptoms; 2. Shame arising from the increasing physical dependence and need for help induced by PD; 3. Shame arising from the patient's assumption of breaking certain social rules; 4. Shame arising from the deteriorated body image; 5. Consequence of related shame and embarrassment on patients' health-related quality of life; 6. Stigmatization). The validation of this scale will give a tool for physicians and researchers to better understand the impact of PD on patient's quality of life.
- Conditions
- Parkinson's Disease, Non-motor Symptoms
- Keywords
- Parkinson's Disease, Non-motor symptoms, Scales for non-motor symptoms, Validation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with neuropsychiatric fluctuations | PD patients with neuropsychiatric fluctuations (≥ 2 positive answers in QUICK test) | |
| Patients without neuropsychiatric fluctuations | PD patients without neuropsychiatric fluctuations (≤ 1 positive answer in QUICK test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NFS score
Measured: 2 weeks (2 assessments in a time span of 2 weeks)
SPARK score
Measured: 2 weeks (2 assessments in a time span of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start3 Dec 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Paul Krack, MD, PhD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366804
- Sponsor's protocol ID
- 2020-00303
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2020
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04366804
- Acronym / sponsor ID
- 2020-00303
- Conditions
- Parkinson's Disease, Non-motor Symptoms
- Keywords
- Parkinson's Disease, Non-motor symptoms, Scales for non-motor symptoms, Validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Carlos III Health Institute
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This project is a prospective international multicentre study to validate two new rating scales in different languages: the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale.
The project population consists a minimum of 300 PD patients with and without fluctuations in the participant countries: Spain, Germany, France, Switzerland, Romania and Greece.
The NFS is specifically designed to detect neuropsychiatric fluctuations between off- and on-medication condition in PD. It is composed of 20 items, 10 items measuring the on-neuropsychological symptoms and 10 items for the off-neuropsychological manifestations. The validation of this scale, based on the most frequently experienced symptoms by the patients, would allow a crucial breakthrough in the improvement of management of PD patients.
Shame and embarrassment are poorly recognized by physicians in PD. PD-related shame and embarrassment may emerge from motor and non-motor symptoms, from self-perception of inadequacy due to loss of autonomy and need for help, or from perceived deterioration of body image. The current available scales are not specific for PD. Based on reports of persons affected with PD and a literature review about shame and stigmatization in PD a 25-items self-questionnaire for shame and embarrassment in PD was created. The scale includes 6 different subscales (1. Shame arising from PD symptoms; 2. Shame arising from the increasing physical dependence and need for help induced by PD; 3. Shame arising from the patient's assumption of breaking certain social rules; 4. Shame arising from the deteriorated body image; 5. Consequence of related shame and embarrassment on patients' health-related quality of life; 6. Stigmatization). The validation of this scale will give a tool for physicians and researchers to better understand the impact of PD on patient's quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with neuropsychiatric fluctuations | – | –PD patients with neuropsychiatric fluctuations (≥ 2 positive answers in QUICK test) |
| Patients without neuropsychiatric fluctuations | – | –PD patients without neuropsychiatric fluctuations (≤ 1 positive answer in QUICK test) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The project population consists of PD patients with and without neuropsychiatric fluctuations attending routine visits to movement disorders clinics in the participant countries. Only patients capable of giving informed consent will be considered for participation in this project.
Key inclusion criteria (4 listed)
- Written informed consent;
- PD, according to the MDS criteria;
- Age of participants > 30 and < 75 years;
- Being fluent in the language in which the scales are applied.
Key exclusion criteria (1 listed)
- 1. Presence of PD dementia (defined as MoCA score < 24).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NFS score
Time frame: 2 weeks (2 assessments in a time span of 2 weeks)
SPARK score
Time frame: 2 weeks (2 assessments in a time span of 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Krack, MD, PhD principal investigator
Insel Gruppe AG, University Hospital Bern
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Non-motor Symptoms, run by Insel Gruppe AG, University Hospital Bern at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, France, Germany, Greece, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines Debove, MD (+41 31 63 2 79 24, ines.debove@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NFS score (time frame: 2 weeks (2 assessments in a time span of 2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.