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

NCT ID: NCT03517059

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-11

Study Completion Date

2018-11-12

Brief Summary

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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

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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

Conditions

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Parkinson Disease

Keywords

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Levodopa axial symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PD patients

30 PD patients in ON and OFF levodopa conditions

No interventions assigned to this group

Healthy control subjects

30 age matched healthy control subjects

No interventions assigned to this group

Neurological control subjects

10 patients with defined supra nuclear palsy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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France Parkinson Association

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline MOREAU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHRU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01544-47

Identifier Type: OTHER

Identifier Source: secondary_id

2015_89

Identifier Type: -

Identifier Source: org_study_id