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OpenTrials
Completed

NCT Number: NCT02859805

Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient

The objective of this study is to validate a diagnostic tool severity of these common non-motor manifestations, disturbing and little recognized as a self-questionnaire. This assessment tool used on different subgroups of patients (free from any treatment at an early stage of the disease and the stage of motor complications) will better understand the natural history of the non-motor fluctuations (FNM)

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient aged 30 or over Patient having an Parkinson's disease Patient hospitalized in one of the clinical sites participating in the project Patient have agreed to participate in the study subject that masters the French language and able to fulfill the self-questionnaire.

Exclusion criteria

Patient aged under 30 Patient can not answer the self-administered questionnaire Patient has not agreed to participate in the study.

Treatment and study plan

validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients

Other

Primary outcomes

  1. Quality of life

    Time frame: 2 years

    Self questionnaires with Beck Depression Scale

  2. Quality of life

    Time frame: 2 years

    use of measurement scales Quality of Life; PDQ-39 it's a 39-item Parkinson's disease questionnaire (Record socio-demographic information)

Secondary outcomes

  1. Socio-demographic data

    Time frame: 2 years

    age, sex, socioeconomic status,

  2. clinical evaluation

    Time frame: 2 years

    clinical form of the disease

  3. clinical evaluation

    Time frame: 2 years

    current treatments and comorbidities

  4. clinical evaluation

    Time frame: 2 years

    Questionnaire administered hetero Q1, Early questionnaire and UPDRS (Unified Parkinson's Disease Rating Scale)

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Aug 9, 2016
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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