Overview

This trial is active, not recruiting.

Conditions parkinson's disease, multiple system atrophy
Treatments mri acquisition, behavioral evaluations
Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Start date January 2013
End date June 2016
Trial size 60 participants
Trial identifier NCT02428816, 2012-A01252-41, C12-52

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)
mri acquisition
MRI acquisitions
behavioral evaluations
Evaluations about motor abilities, sleep, cognition and lifestyle
(Experimental)
Patients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)
mri acquisition
MRI acquisitions
behavioral evaluations
Evaluations about motor abilities, sleep, cognition and lifestyle

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.
time frame: 1 year

Secondary Outcomes

Measure
correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes
Principal investigator Olivier Rascol, Pr
Description 30 patients with PD and 30 patients with MSA 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Institut National de la Santé Et de la Recherche Médicale, France.