Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes (MultiPAMS)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Multiple System Atrophy; Parkinson's Disease

Treatments: Other: MRI acquisition; Behavioral: behavioral evaluations

Study type: Interventional

Funder types: Other

Identifiers

NCT02428816

C12-52

2012-A01252-41 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

Patients with Parkinson's Disease

Experimental group

Description:

Patients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)

Treatment:

Behavioral: behavioral evaluations

Other: MRI acquisition

Patients with MSA

Experimental group

Description:

Patients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)

Treatment:

Behavioral: behavioral evaluations

Other: MRI acquisition

Controls

Experimental group

Description:

30 healthy controls will be submitted to an MRI acquisition and to behavioural evaluations in a sole visit

Treatment:

Behavioral: behavioral evaluations

Other: MRI acquisition