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

NCT03517059 | Completed DMC

• 2 other identifiers: 2015_892016-A01544-47
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

Levodopa; axial symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the neural network between patients in OFF-drug conditions and healthy control subjects

  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

  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

  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)

  Between two evaluation visits, on average at 3 months (baseline- 3 months)

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease (PD)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• France Parkinson Association: collaborator

Study Sites (1)

Hôpital Roger Salengro, CHRU

Lille, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Caroline MOREAU, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 7, 2018
• Study Start: May 11, 2017
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: December 23, 2025

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)