---
title: Validate scales measuring mood fluctuations
nct_id: NCT04366804
status: RECRUITING
sponsor: Insel Gruppe AG, University Hospital Bern
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT04366804"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04366804"
last_fetched: "2026-05-10T14:07:44.216Z"
source: "Parkinson's Pathways (curated)"
---
# Validate scales measuring mood fluctuations

**Goal (in five words):** Validate scales measuring mood fluctuations

**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

**Trial ID:** [NCT04366804](https://clinicaltrials.gov/study/NCT04366804)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Insel Gruppe AG, University Hospital Bern
- **Target Enrollment:** 300 participants
- **Start Date:** 2020-12-03
- **Completion Date:** 2025-09-30
- **Conditions:** Parkinson's Disease, Non-motor Symptoms

## Summary For Families

The goal is to see whether two questionnaires reliably measure neuropsychiatric fluctuations and feelings of shame in people with Parkinson's, so clinicians and researchers can better track mood swings, anxiety, apathy and the social distress that often comes with the disease across countries and languages. The approach is observational, having participants complete the Neuropsychiatric Fluctuations Scale, which captures short-term changes in mood and related symptoms, and the SPARK scale, which measures shame and stigma, then testing the questionnaires for consistency, validity and cross-cultural accuracy, with no drugs or devices involved. Eligibility is adults 30 to 75 with Parkinson's by MDS criteria, fluent in the language used for the scales, able to give written consent, and without PD dementia, defined as a MoCA score below 24.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
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).
```

## Locations (8)

- Centre hospitalier régional universitaire de Besançon, Besançon, France _(47.2488, 6.0182)_
- Universitätsklinikum Carl Gustav Carus, Dresden, Germany _(51.0509, 13.7383)_
- Aristotle University of Thessaloniki, Thessaloniki, Greece _(40.6407, 22.9349)_
- Transilvania University, Brasov, Romania _(45.6486, 25.6061)_
- Hospital Universitario Burgos, Burgos, Spain _(42.3411, -3.7018)_
- Ruber International Hospital, Madrid, Spain _(40.4165, -3.7026)_
- Insel Gruppe AG University Hospital Bern, Bern, Switzerland _(46.9481, 7.4474)_
- King's College London, London, United Kingdom _(51.5085, -0.1257)_

## Central Contacts

- Ines Debove, MD — (CONTACT) — +41 31 63 2 79 24 — ines.debove@insel.ch

---

*Canonical: https://parkinsonspathways.com/trial/NCT04366804*  
*HTML version: https://parkinsonspathways.com/trial/NCT04366804*  
*Source data: https://clinicaltrials.gov/study/NCT04366804*