NFS-SPARK
Research type
Research Study
Full 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
IRAS ID
278019
Contact name
Paul Krack
Contact email
Sponsor organisation
University Hospital Bern
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The goal of this prospective international multicentre 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).
The NFS and SPARK scales consist of self-completion questionnaires for patients with PD. They will be adapted to the languages of participating countries following a translation-back translation procedure. In a preliminary test, the translated scales will undergo cognitive pretesting to confirm absence of cognitive impairment and presence of fluctuations. Participants will then complete the NFS and SPARK questionnaires.
After conclusion of cognitive pretesting, 300 participants (50 per language) using a 2:1 ratio (two patients with fluctuations for each without) will be recruited for the validation process, during which 5 rater-based scales will be completed including the MoCA to eliminate patients with cognitive impairment and the QUICK Test to distinguish fluctuating from non-fluctuating participants.
Participants without motor fluctuations will complete the NFS and SPARK scales plus a motor assessment (MDS-UPDRS) and self-assessed scales.
Participants with motor fluctuations will complete the NFS and SPARK scales plus a motor assessment and self-assessed scales in both OFF and ON states.
Inclusion & exclusion criteria:
1. Written informed consent;
2. PD, according to the MDS criteria;
3. Age of participants > 30 and < 75 years;
4. Fluency in specific language in which the scales are applied;
5. Absence of PD dementia (defined as MoCA score ≥ 24)Project duration: 21 - 24 months.
The international validation of the NFS and SPARK scales will allow a crucial breakthrough in the improvement of management of patients with PD and well justifies the time and effort for participants to complete the scale questionnaires.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0221
Date of REC Opinion
20 Apr 2023
REC opinion
Further Information Favourable Opinion