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Completed

NCT Number: NCT02428816

Evaluation of a Multimodal Neuroimaging Method for Diagnosis 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.

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Key information

Conditions

Parkinson's Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Primary Dysautonomias Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inserm Umr 825

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI acquisition

Other

MRI acquisitions

behavioral evaluations

Behavioral

Evaluations about motor abilities, sleep, cognition and lifestyle

Primary outcomes

  1. 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

  1. correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: MultiPAMS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2015
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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