Parkinson's DiseasePARKIMAGENCT02445469
Magnetic Resonance Imaging in the Diagnosis of Parkinsonian Syndromes
A study testing MRI exam of the brain in people with Parkinson's Disease and Multiple System Atrophy, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- What is being tested?
- MRI exam of the brain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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 :
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- 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.
Who cannot join
- 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 :
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- •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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neuroradiologie, Hopital Gui de Chauliac, CHU de Montpellier
Montpellier, France, 34295
About this study
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.
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.
Read the 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).
- Conditions
- Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Vascular Parkinsonism
- Being tested
- MRI exam of the brain
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI exam of the brainOther
MRI exam of the brain
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Other | MRI exam of the brain Receives: Other: MRI exam of the brain |
| Multiple System Atrophy | Other | MRI exam of the brain Receives: Other: MRI exam of the brain |
| Progressive Supranuclear Palsy | Other | MRI exam of the brain Receives: Other: MRI exam of the brain |
| Vascular parkinsonism | Other | MRI exam of the brain Receives: Other: MRI exam of the brain |
| Healthy volunteers | Other | MRI exam of the brain Receives: Other: MRI exam of the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: The results obtained are sufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Nicolas Menjot de Champfleur, Medical PHD, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445469
- Sponsor's protocol ID
- 8743
- Acronym
- PARKIMAGE
- Status last verified
- Mar 2017
- First submitted
- 7 May 2015
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02445469
- Acronym / sponsor ID
- PARKIMAGE / 8743
- Conditions
- Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Vascular Parkinsonism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results obtained are sufficient
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Dec 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | Other | Other: MRI exam of the brainMRI exam of the brain |
| Multiple System Atrophy | Other | Other: MRI exam of the brainMRI exam of the brain |
| Progressive Supranuclear Palsy | Other | Other: MRI exam of the brainMRI exam of the brain |
| Vascular parkinsonism | Other | Other: MRI exam of the brainMRI exam of the brain |
| Healthy volunteers | Other | Other: MRI exam of the brainMRI exam of the brain |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- For Both patients and healthy volunteers :
- 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.
Key exclusion criteria (11 listed)
- For Both patients and healthy volunteers :
- For the patients :
- •Patient treated by neuroleptics
- For the healthy volunteers :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI exam of the brainMRI exam of the brain | Other | Healthy volunteers, Multiple System Atrophy, Parkinson's disease, Progressive Supranuclear Palsy, Vascular parkinsonism |
Primary outcome
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.
1 secondary outcome
Diffusion tensor imaging
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The results obtained are sufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Menjot de Champfleur, Medical PHD principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI exam of the brain in people with Parkinson's Disease and Multiple System Atrophy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The results obtained are sufficient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative susceptibility mapping (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.