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Magnetic Resonance Imaging in the Diagnosis of Parkinsonian Syndromes (PARKIMAGE)

Primary Purpose

Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI exam of the brain
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For Both patients and healthy volunteers :

    • Age limits ≥ 70 et ≤ 90 years
    • Subject able to understand the nature, the aim and the methodology of the study.
    • Collection of the infomed consent
    • Affiliation or recipient with the mode of social security.
  • For the patients :

Parkinsonian Syndrome began after 65 years defined as Parkinson's disease Multiple System Atrophy (AMS), Progressive Supranuclear Palsy, Vascular Parkinson

  • For the healthy volunteers :

The healthy volunteers will be selected according to the age and the of the study's patients.

Exclusion Criteria:

  • For Both patients and healthy volunteers :

    • Person with majority age protected by the law (supervision or trusteeship).
    • Loss of liberty per court order or administative
    • Subject presenting contraindications in MRI (valve of ventricular diversion, Ferromagnetic foreign bodies, pace-maker, Implantable defibrillator (ICD), Cochlear hearing implant, Claustrophobia, ….)
    • Antecedent of serious cranial trauma (according to classification) of ischeamic stroke ou intracranial hematoma.
  • For the patients :

    •Patient treated by neuroleptics

  • For the healthy volunteers :

    • Antecedent of neurological desease
    • Antecedent of psychiatric trouble de trouble psychiatrique (Except anxio-depressive disorder)
    • In period of exclusion relative to another protocol or which the annual amount of the allowances maximum of 4500 € was reached.

Sites / Locations

  • Service de Neuroradiologie, Hopital Gui de Chauliac, CHU de Montpellier

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Parkinson's disease

Multiple System Atrophy

Progressive Supranuclear Palsy

Vascular parkinsonism

Healthy volunteers

Arm Description

MRI exam of the brain

MRI exam of the brain

MRI exam of the brain

MRI exam of the brain

MRI exam of the brain

Outcomes

Primary Outcome Measures

Quantitative susceptibility mapping
Susceptibility weighted imaging raw data are preprocessed to obtain magnitude and phase images for each echo time. Quantitative susceptibility maps are then generated using a in-house software.

Secondary Outcome Measures

Diffusion tensor imaging
Diffusion tensor imaging data are acquired and corrected for distortions due to eddy currents in the gradient coils. They are processed using FSL software to generate fractional anisotropy (FA), mean diffusivity (MD) and the three eigenvalues (λ1, λ2, λ3) used to calculate axial diffusivity (AD=λ1) and radial diffusivity (RD=[λ2 + λ3]/2) maps.

Full Information

First Posted
May 7, 2015
Last Updated
March 30, 2017
Sponsor
University Hospital, Montpellier
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02445469
Brief Title
Magnetic Resonance Imaging in the Diagnosis of Parkinsonian Syndromes
Acronym
PARKIMAGE
Official Title
Contribution of Magnetic Resonance Imaging (Diffusion Tensor Imaging and Magnetic Susceptibility Imaging and Resting Activation Imaging) in the Diagnosis of Parkinsonian Syndromes in Elderly Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The results obtained are sufficient
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Parkinsonian syndrome is clinically characterized by the presence of resting tremor, rigidity, bradykinesia and postural instability. Parkinsonian disorders include Parkinson's disease (PD), progressive supranuclear palsy (PSP), corticobasal dementia (CBD), multiple system atrophy (MSA) and vascular parkinsonism (VP). Each of these diseases has a singular physiopathological origin, course and prognosis. Numerous imaging studies consequently aimed at finding markers to early make the distinction between the different types of parkinsonism, in order to identify patients who could benefit from dopaminergic agonist therapy. Excessive iron deposition in the subcortical and brainstem nuclei has been described in numerous neurodegenerative disorders including Parkinson's disease. Increased iron levels are more frequent in area that are rich in dopaminergic neurons and have been implicated in the development of movement disorders, the distribution of areas with increased iron deposition however varying according to parkinsonism types. Iron deposition quantification could thus potentially help in differentiating parkinsonism types and could improve therapy guidance. Quantitative susceptibility mapping (QSM) locally estimates the magnetic susceptibility of brain tissues based on gradient-echo signal phase. The local susceptibility being sensitive to the presence of paramagnetic susbtances, QSM allows the non-invasive evaluation of iron distribution and quantification in the brain with high image quality (Liu et al., 2013). However, since iron deposition followed an exponential curve during normal aging in most of the basal ganglia the potential of QSM to distinguish between healthy and parkinsonian subjects in elderly remains unclear. The aim of this study was thus to determine susceptibility values in the basal ganglia of elderly patients with parkinsonian syndromes, to compare these values to healthy aged-matched controls and between parkinsonian syndrome types. Secondly, investigators aimed to evaluate microstructural changes in the basal ganglia using diffusion tensor imaging (DTI) in the same population and to determine whether susceptibility and DTI parameter changes are correlated. Finally investigators sought to assess the relation between susceptibility/DTI parameter values in the basal ganglia and behavioral measures of motor and cognitive abilities.
Detailed Description
Elderly patients with parkinsonian syndrome and healthy age-matched controls are enrolled in this study. The subjects all undergo a brain MRI exam. Controls are selected to match the age distribution of patients. Clinical evaluation The day of the brain MRI examination, all patients undergo a neurological and neuropsychological evaluation. Diagnoses are established by a neurologist experienced with parkinsonian syndromes according to established guidelines: the UK Parkinson's Disease Society Brain Bank criteria for idiopathic PD, the National Institute of Neurological Disorders and Stroke and the Society for Progressive Supranuclear Palsy criteria for progressive supranuclear palsy, Lang's criteria for corticobasal dementia, Gilman's criteria for multiple system atrophy and Zijlmans's criteria for vascular parkinsonism. Impairment of the motor function related to parkinsonian syndrome is assessed using the Hoehn and Yahr scale (range 0-5), the Schwab and England Activities of Daily Living scale (range 0-100%), the Unified Parkinson's Disease Rating Scale (UPDRS, range 0-199) and the Short Motor Disability scale (range 0-17). Cognitive impairment is assessed using the Mini Mental Sate Examination (MMSE) score (range 0-30), the Grober and Buschke verbal-learning test (range 0-16), a semantic-processing task (LEXIS test, range 0-64), the forward/backward Digit span task (range 0-17) of the third Wechsler Adult Intelligence Scale and the Rey-Osterrieth Complex-Figure (ROCF) test (range 0-36) to assess visuospatial abilities, attention, executive function and working memory. The Mattis Dementia-Rating scale (range 0-144) and the Beck Depression Inventory (range 0-63) are performed to look for depression. The Educational Attainment and the National Institute of Health Stroke Score (NIHSS) (range 0-42) are also recorded. MRI acquisition and processing. All patients undergo a brain MRI on a 3-Tesla scanner including 3D triple echo gradient echo acquisition to generate susceptibility weighted images, T1-weighted magnetisation-prepared rapid 3D gradient-echo (MPRAGE) and diffusion tensor imaging acquisition. Susceptibility weighted imaging raw data are preprocessed to obtain magnitude and phase images for each echo time. Quantitative susceptibility maps are then generated using SPM8 software (Statistical Parametric Mapping, Wellcome Department of Cognitive Neurology, Institute of Neurology, London, UK; http://www.fil.ion.ucl.ac.uk/spm/, Matlab 2014a, The MathWorks, Natick, MA, USA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Vascular Parkinsonism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's disease
Arm Type
Other
Arm Description
MRI exam of the brain
Arm Title
Multiple System Atrophy
Arm Type
Other
Arm Description
MRI exam of the brain
Arm Title
Progressive Supranuclear Palsy
Arm Type
Other
Arm Description
MRI exam of the brain
Arm Title
Vascular parkinsonism
Arm Type
Other
Arm Description
MRI exam of the brain
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
MRI exam of the brain
Intervention Type
Other
Intervention Name(s)
MRI exam of the brain
Intervention Description
MRI exam of the brain
Primary Outcome Measure Information:
Title
Quantitative susceptibility mapping
Description
Susceptibility weighted imaging raw data are preprocessed to obtain magnitude and phase images for each echo time. Quantitative susceptibility maps are then generated using a in-house software.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Diffusion tensor imaging
Description
Diffusion tensor imaging data are acquired and corrected for distortions due to eddy currents in the gradient coils. They are processed using FSL software to generate fractional anisotropy (FA), mean diffusivity (MD) and the three eigenvalues (λ1, λ2, λ3) used to calculate axial diffusivity (AD=λ1) and radial diffusivity (RD=[λ2 + λ3]/2) maps.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For Both patients and healthy volunteers : Age limits ≥ 70 et ≤ 90 years Subject able to understand the nature, the aim and the methodology of the study. Collection of the infomed consent Affiliation or recipient with the mode of social security. For the patients : Parkinsonian Syndrome began after 65 years defined as Parkinson's disease Multiple System Atrophy (AMS), Progressive Supranuclear Palsy, Vascular Parkinson For the healthy volunteers : The healthy volunteers will be selected according to the age and the of the study's patients. Exclusion Criteria: For Both patients and healthy volunteers : Person with majority age protected by the law (supervision or trusteeship). Loss of liberty per court order or administative Subject presenting contraindications in MRI (valve of ventricular diversion, Ferromagnetic foreign bodies, pace-maker, Implantable defibrillator (ICD), Cochlear hearing implant, Claustrophobia, ….) Antecedent of serious cranial trauma (according to classification) of ischeamic stroke ou intracranial hematoma. For the patients : •Patient treated by neuroleptics For the healthy volunteers : Antecedent of neurological desease Antecedent of psychiatric trouble de trouble psychiatrique (Except anxio-depressive disorder) In period of exclusion relative to another protocol or which the annual amount of the allowances maximum of 4500 € was reached.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Menjot de Champfleur, Medical PHD
Organizational Affiliation
UH Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neuroradiologie, Hopital Gui de Chauliac, CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Magnetic Resonance Imaging in the Diagnosis of Parkinsonian Syndromes

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