Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease

NCT06701955 | Recruiting

• 2 other identifiers: 38RC24.01962024-A01403-44
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on neuropsychiatric fluctuations (NPF) in Parkinson's disease. Due to the lack of specific assessment tools, we developed the Neuropsychological Fluctuations Scale (NFS), a 20-item questionnaire. Recent studies have confirmed its reliability, sensitivity, and validity. To finalize its validation, assessing its test-retest reliability is an essential next step.

Conditions

Parkinson's Disease

Keywords

neuropsychiatric fluctuations; scale validation; psychometric caracteristics; non-motor symptoms

Outcome Measures

Primary Outcomes (1)

• validation of test-retest reliabililty

  validation of test-retest reliabililty of the neuropsychiatric fluctuations scale

  4 weeks

Study Arms (1)

sequence of intervention

OTHER

self administered questionnaires at different time points..

Other: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam OTHER

self administered questionnaires

sequence of intervention

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 30 and ≤ 75 years
• Idiopathic Parkinson's disease (according to the criteria of the Movement Disorders Society)
• Presence of motor fluctuations described by the patient, their relatives, or identified by the clinician
• Stability of antiparkinsonian treatment for at least one month
• Mastery of the French language
• Able to give consent.
• Affiliated to the social security system

You may not qualify if:

• Parkinsonian syndrome other than idiopathic Parkinson's disease
• Dementia (MoCa \< 23)
• No antiparkinsonian treatment or treatment modified for less than one month
• Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons subject to a legal protection measure or unable to express their consent))

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHUGA

Grenoble, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires; Restraint, Physical

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Emmanuelle Schmitt, PHD

CONTACT

+33 4 76765791; eschmitt@chu-grenoble.fr

Andrea Kistner

CONTACT

akistner@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)