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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03517059
Acronym
Prodygi-II
Enrollment
29
Registered
2018-05-07
Start date
2017-05-11
Completion date
2018-11-12
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Levodopa, axial symptoms

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

Interventions

None listed

Sponsors

France Parkinson Association
CollaboratorOTHER
University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in the neural network between patients in OFF-drug conditions and healthy control subjectsBetween two evaluation visits, on average at 3 months (baseline- 3 months)Measure evaluated by functional MRI during the realisation of two motor tasks
Change in the neural network between OFF-drug condition and ON-drug condition in patientsBetween two evaluation visits, on average at 3 months (baseline- 3 months)Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks
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)Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026