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Completed

NCT Number: NCT03517059

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

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHRU

Lille, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in the neural network between patients in OFF levodopa conditions and control subjects

    Time frame: Between 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 outcomes

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

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

    Measure evaluated by functional MRI during the realisation of two motor tasks

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

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

    Measure evaluated by resting state functional MRI

  3. Change in the neural network between OFF-drug condition and ON-drug condition in patients

    Time frame: 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

  4. Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • France Parkinson Association

Registry information

Official study title

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

Acronym: Prodygi-II

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 7, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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