International Validation of Two Non-motor Scales in PD (NFS and SPARK)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-75
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Patients with neuropsychiatric fluctuations
Group B: Patients without neuropsychiatric fluctuations

Trial outcomes

Primary outcomes

1

NFS score

Time frame
2 weeks (2 assessments in a time span of 2 weeks)
2

SPARK score

Time frame
2 weeks (2 assessments in a time span of 2 weeks)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Carlos III Health Institute

Collaborator