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

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ClinicalTrials.gov Identifier: NCT02445469
Recruitment Status : Terminated (The results obtained are sufficient)
First Posted : May 15, 2015
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Multiple System Atrophy Progressive Supranuclear Palsy Vascular Parkinsonism Other: MRI exam of the brain Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : December 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Parkinson's disease
MRI exam of the brain
Other: MRI exam of the brain
MRI exam of the brain

Multiple System Atrophy
MRI exam of the brain
Other: MRI exam of the brain
MRI exam of the brain

Progressive Supranuclear Palsy
MRI exam of the brain
Other: MRI exam of the brain
MRI exam of the brain

Vascular parkinsonism
MRI exam of the brain
Other: MRI exam of the brain
MRI exam of the brain

Healthy volunteers
MRI exam of the brain
Other: MRI exam of the brain
MRI exam of the brain




Primary Outcome Measures :
  1. Quantitative susceptibility mapping [ Time Frame: 1 month ]
    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 :
  1. Diffusion tensor imaging [ Time Frame: 1 month ]
    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.



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Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445469


Locations
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France
Service de Neuroradiologie, Hopital Gui de Chauliac, CHU de Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Novartis
Investigators
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Principal Investigator: Nicolas Menjot de Champfleur, Medical PHD UH Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02445469     History of Changes
Other Study ID Numbers: 8743
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Parkinson Disease
Atrophy
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms