Clinical trial NCT03517059: Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
Official title: Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Levodopa
axial symptoms
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: France Parkinson Association
First posted: 2018-05-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease (PD)

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the neural network between patients in OFF levodopa conditions and control subjects
timeFrame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Secondary outcomes:
measure: Change in the neural network between patients in OFF-drug conditions and healthy control subjects
timeFrame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
measure: Change in the neural network between patients in OFF-drug conditions and healthy control subjects
timeFrame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
measure: Change in the neural network between OFF-drug condition and ON-drug condition in patients
timeFrame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
measure: Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy)
timeFrame: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Caroline MOREAU, MD
role: PRINCIPAL_INVESTIGATOR
References: