Clinical trial NCT02428816: Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes
Official title: Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Multiple System Atrophy
Keywords: differential diagnosis
multimodal MRI
Parkinson's Disease
Multiple System Atrophy
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2015-04-29
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain
timeFrame: 1 year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Inserm Umr 825
Study officials:
affiliation: INSERM UMR 825, France
name: Olivier Rascol, Pr
role: PRINCIPAL_INVESTIGATOR
References: