Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease

Study Overview
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Brief Summary
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Pilot study: Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD) Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations

Detailed Description
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Prospective, clinical assessment of : Cognition and diadochokinetic task during fMRI in 30 PD patients (in off and on condition) Motor assessment using VICON gait and balance analysis Pulmonary functional testing in OFF and ON drug condition Quality of life Clinical neurological MDS UPDRS , N Fog questionnaire ENT and speech therapist evaluation in OFF and ON drug condition

Official Title
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Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's Disease group : Patients with Parkinson's Disease, who where included in the PRODYGI-1 cohort still meeting the MP criteria, Always followed in the service of neurology and pathology of the movement. Pathological control group: Patients suffering from Richardson syndrome. Aged over 18 Healthy control group: Age-matched (± 5 years) Recruited on the basis of volunteering. free from any progressive neurological pathology after clinical examination and MoCA. Exclusion Criteria: For all groups: Pregnant or lactating woman Extra-neurological severe respiratory pathology Terminal heart failure Contraindication to MRI Refusal / withdrawal / inability to give consent ENT pathology.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD patients<br>30 PD patients in ON and OFF levodopa conditions | |
| Healthy control subjects<br>30 age matched healthy control subjects | |
| Neurological control subjects<br>10 patients with defined supra nuclear palsy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the neural network between patients in OFF levodopa conditions and control subjects | Measure evaluated by functional MRI during the realisation of a cognitive task: symbol digit modality test | Between two evaluation visits, on average at 3 months (baseline- 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the neural network between patients in OFF-drug conditions and healthy control subjects | Measure evaluated by functional MRI during the realisation of two motor tasks | Between two evaluation visits, on average at 3 months (baseline- 3 months) | 
| Change in the neural network between patients in OFF-drug conditions and healthy control subjects | Measure evaluated by resting state functional MRI | Between two evaluation visits, on average at 3 months (baseline- 3 months) | 
| Change in the neural network between OFF-drug condition and ON-drug condition in patients | Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks | Between two evaluation visits, on average at 3 months (baseline- 3 months) | 
| Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy) | Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks | Between two evaluation visits, on average at 3 months (baseline- 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levodopa, axial symptoms