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

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

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

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Caroline MOREAU, MD; Phone Number: +33 3.20.44.67.52; Email: caroline.moreau@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Roger Salengro, CHRU
    • Principal Investigator: Caroline Moreau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease (PD)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
PD patients; 30 PD patients in ON and OFF levodopa conditions
Healthy control subjects; 30 age matched healthy control subjects
Neurological control subjects; 10 patients with defined supra nuclear palsy

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: France Parkinson Association
• Investigators: Principal Investigator: Caroline MOREAU, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Levodopa; axial symptoms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Language Disorders; Communication Disorders; Speech Disorders; Articulation Disorders; Parkinson Disease; Dysarthria
• Other Study ID Numbers: 2015_89; 2016-A01544-47 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No