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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 February 2021 |
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Main ID: |
NCT02428816 |
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Date of registration:
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28/01/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes
MultiPAMS |
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Scientific title:
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Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes |
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Date of first enrolment:
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January 24, 2013 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02428816 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Olivier Rascol, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSERM UMR 825, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- informed consent signed
- right handed patients
- Mini Mental Score > 22
- no other neurological disease than Parkinson's Disease (PD) or Multiple System Atrophy
(MSA)
- non-demented patients reached by PD or MSA (according to diagnosis criteria from UK PD
Brain Bank and from Gilman and colleagues, 1998, for PD and MSA respectively)
- for PD patients only : Hoehn and Yahr score from 2 to 3
Exclusion Criteria:
- claustrophobia
- contraindications to MRI (cardiac or auditive prothesis, pacemakers, cerebral clip,
stimulating electrodes)
- pregnant women
- major neuropsychiatric disease
- refusal to be informed in case of cerebral anomaly detected during MRI acquisition
- uncompensated thyroid deficit
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple System Atrophy
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Parkinson's Disease
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Intervention(s)
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Other: MRI acquisition
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Behavioral: behavioral evaluations
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Primary Outcome(s)
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The primary outcome measure to discriminate individual patients and patients with MPI and AMS through multimodal MRI isolating multiparametric spatial signature resulting from a combination of markers in multimodal imaging.
[Time Frame: 1 year]
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Secondary Outcome(s)
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correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain
[Time Frame: 1 year]
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Secondary ID(s)
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2012-A01252-41
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C12-52
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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