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Clinical Trials/NCT02428816
NCT02428816
Completed
Not Applicable

Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country94 target enrollmentJanuary 24, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
94
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. Patients will be compared with healthy controls.

Detailed Description

30 patients with PD, 30 patients with MSA and 30 healthy controls will be examined in a 3Tesla MRI. The aim of our project is to demonstrate that our multimodal MRI method can discriminate both diseases with a similar clinical presentation and monitor the progress of the disease. CIC's expertise in recruitment and assessment of patients, and the powers of the INSERM U825 in terms of development and processing in neuroimaging guarantee the feasibility of the project and its successful completion.

Registry
clinicaltrials.gov
Start Date
January 24, 2013
End Date
July 28, 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain(1 year)

Study Sites (1)

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