Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes

NCT ID: NCT02428816

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-24

Study Completion Date

2016-07-28

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease Multiple System Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

MRI acquisition

Intervention Type OTHER

MRI acquisitions

behavioral evaluations

Intervention Type BEHAVIORAL

Evaluations about motor abilities, sleep, cognition and lifestyle

Patients with MSA

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

Group Type EXPERIMENTAL

MRI acquisition

Intervention Type OTHER

MRI acquisitions

behavioral evaluations

Intervention Type BEHAVIORAL

Evaluations about motor abilities, sleep, cognition and lifestyle

Controls

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

Group Type EXPERIMENTAL

MRI acquisition

Intervention Type OTHER

MRI acquisitions

behavioral evaluations

Intervention Type BEHAVIORAL

Evaluations about motor abilities, sleep, cognition and lifestyle

Interventions

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MRI acquisition

MRI acquisitions

Intervention Type OTHER

behavioral evaluations

Evaluations about motor abilities, sleep, cognition and lifestyle

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Rascol, Pr

Role: PRINCIPAL_INVESTIGATOR

INSERM UMR 825, France

Locations

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Inserm Umr 825

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01252-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

C12-52

Identifier Type: -

Identifier Source: org_study_id

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