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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Non-motor Symptoms; Parkinson's Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04366804

2020-00303

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No 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).

Trial design

300 participants in 2 patient groups

Patients with neuropsychiatric fluctuations

Description:

PD patients with neuropsychiatric fluctuations (≥ 2 positive answers in QUICK test)

Patients without neuropsychiatric fluctuations

Description:

PD patients without neuropsychiatric fluctuations (≤ 1 positive answer in QUICK test)