Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

Study Overview
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Brief Summary
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The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.

Detailed Description
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All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study (Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667) between june 2012 and june 2016. 3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again. The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome. Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.

Official Title
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Improvement of Hypodopaminergic Syndrome With Dopaminergic Treatment in Early Parkinson's Disease

Conditions
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Parkinson Disease, Apathy

Intervention / Treatment
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* Other: Starkstein scale of Apathy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who participated in Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667 Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months Patients with medical insurance signed informed consent Exclusion Criteria: diagnosis other than Parkinson's Disease dementia (Mattis <130) patients protected by law (i.e. pregnant or parturient women)

Ages Eligible for Study
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Minimum Age: 33 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apathetic patients<br>De novo Parkinson's Disease patients with Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the Starkstein scale of apathy | Other: Starkstein scale of Apathy<br>* The degree of apathy will be evaluated with the Starkstein scale of Apathy<br>|
| Non-apathetic patients<br>De novo Parkinson's Disease patients without Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the Starkstein scale of apathy | Other: Starkstein scale of Apathy<br>* The degree of apathy will be evaluated with the Starkstein scale of Apathy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of apathy in Parkinson's disease | Evolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the Starkstein Scale of Apathy. | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of hypodopaminergia in Parkinson's disease | Evolution of hypodopaminergic symptoms in Patients with Parkinson's disease under dopaminergic treatment. Hypodopaminergic symptoms are evaluated with different scales: ECMP (behavioral evaluation in Parkinsons's disease) for depression and anxiety, STAI (State-trait-anxiety inventory, self-assessment-questionnaire for anxiety, BDI (Beck depression inventory) for depression, PFS-16 (Piper Fatigue Sale) for fatigue. Hypodopaminergia is the expressed as the sum of its symptoms. | 1 day | 
| Apparition of hyperdopaminergic symptoms in Parkinson's disease | Apparition of hyperdopaminergic symptoms in patients with Parkinson's disease under dopaminergic treatment, with the questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP) and the ECMP scale. | 1 day | 
| Evolution of impulsivity in Parkinson's disease | Evolution of impulsivity in patients with Parkinson's disease under dopaminergic treatment. Evaluation with a self-assessment-questionnaire (UPPS Impulsive Behavior Scale) | 1 day | 
| Evolution of personality in Parkinson's disease | Evolution of personality in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire Temperament and Character Inventory (TCI). | 1 day | 
| Evolution of pain in Parkinson's disease | Evolution of pain in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire NPSI (Neuropathic Pain Symptom Inventory). | 1 day | 
| Evolution of quality of life in Parkinson's disease | Evolution of quality of life in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire PDQ39 (Parkinson's disease questionnaire). | 1 day | 
| Evolution of somnolence in Parkinson's disease | Evolution of somnolence in patients with Parkinson's disease under dopaminergic treatment with the ECMP scale. | 1 day | 
| Evolution of eating behavior in Parkinson's disease | Evolution of eating behavior in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire Dutch Eating Behavior Questionnaire - DEBQ. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non motor symptoms