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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Multiple System Atrophy
• Intervention / Treatment: Other: MRI acquisition; Behavioral: behavioral evaluations

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Inserm Umr 825

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Parkinson's Disease; Patients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)	Other: MRI acquisition; MRI acquisitions; Behavioral: behavioral evaluations; Evaluations about motor abilities, sleep, cognition and lifestyle
Experimental: Patients with MSA; Patients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)	Other: MRI acquisition; MRI acquisitions; Behavioral: behavioral evaluations; Evaluations about motor abilities, sleep, cognition and lifestyle
Experimental: Controls; 30 healthy controls will be submitted to an MRI acquisition and to behavioural evaluations in a sole visit	Other: MRI acquisition; MRI acquisitions; Behavioral: behavioral evaluations; Evaluations about motor abilities, sleep, cognition and lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain	1 year

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Olivier Rascol, Pr, INSERM UMR 825, France

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2013
• Primary Completion (Actual): July 28, 2016
• Study Completion (Actual): July 28, 2016

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Multiple System Atrophy; differential diagnosis; multimodal MRI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Parkinson Disease; Atrophy; Multiple System Atrophy; Shy-Drager Syndrome; Parkinsonian Disorders
• Other Study ID Numbers: C12-52; 2012-A01252-41 (Registry Identifier: IDRCB)