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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04366804

Enrollment

300

Registered

2020-04-29

Start date

2020-12-03

Completion date

2025-12-31

Last updated

2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-motor Symptoms, Parkinson's Disease

Keywords

Parkinson's Disease, Non-motor symptoms, Scales for non-motor symptoms, Validation

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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
NFS score	2 weeks (2 assessments in a time span of 2 weeks)
SPARK score	2 weeks (2 assessments in a time span of 2 weeks)

Countries

France, Germany, Greece, Romania, Spain, Switzerland, United Kingdom

Contacts

Primary ContactInes Debove, MD

ines.debove@insel.ch+41 31 63 2 79 24

Outcome results