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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03517059
Other study ID # 2015_89
Secondary ID 2016-A01544-47
Status Recruiting
Phase
First received
Last updated
Start date May 11, 2017
Est. completion date September 2020

Study information

Verified date July 2019
Source University Hospital, Lille
Contact Caroline MOREAU, MD
Phone 3.20.44.67.52
Email caroline.moreau@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date September 2020
Est. primary completion date May 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Roger Salengro, CHRU Lille

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille France Parkinson Association

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in the neural network between patients in OFF-drug conditions and healthy control subjects Measure evaluated by functional MRI during the realisation of two motor tasks Between two evaluation visits, on average at 3 months (baseline- 3 months)
Secondary Change in the neural network between patients in OFF-drug conditions and healthy control subjects Measure evaluated by resting state functional MRI Between two evaluation visits, on average at 3 months (baseline- 3 months)
Secondary Change in the neural network between OFF-drug condition and ON-drug condition in patients Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks Between two evaluation visits, on average at 3 months (baseline- 3 months)
Secondary Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy) Measure evaluated by functional MRI, during the realisation of one cognitive task and two motor tasks Between two evaluation visits, on average at 3 months (baseline- 3 months)
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