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

Parkinson Disease Clinical Trial

— Prodygi-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03517059
• Other study ID #: 2015_89
• Secondary ID: 2016-A01544-47
• Status: Recruiting
• Start date: May 11, 2017
• Est. completion date: September 2020

Study information

• Verified date: July 2019
• Source: University Hospital, Lille
• Contact: Caroline MOREAU, MD
• Phone: 3.20.44.67.52
• Email: caroline.moreau[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysarthria
• Parkinson Disease

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	France Parkinson Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)