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

U

University Hospital, Lille

Status

Unknown

Conditions

Parkinson Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03517059
2016-A01544-47 (Other Identifier)
2015_89

Details and patient eligibility

About

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

Full 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

Enrollment

70 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

70 participants in 3 patient groups

PD patients
Description:
30 PD patients in ON and OFF levodopa conditions
Healthy control subjects
Description:
30 age matched healthy control subjects
Neurological control subjects
Description:
10 patients with defined supra nuclear palsy

Trial contacts and locations

1

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Central trial contact

Caroline MOREAU, MD

Data sourced from clinicaltrials.gov

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