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CompletedNCT02428816MultiPAMSUpdated Feb 9, 2021

Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes

An interventional study of MRI acquisition and behavioral evaluations in Parkinson's Disease and Multiple System Atrophy, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. Patients will be compared with healthy controls.

Read the 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.

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Conditions studied

  • Parkinson's Disease
  • Multiple System Atrophy

Keywords

  • differential diagnosis
  • multimodal MRI
  • Parkinson's Disease
  • Multiple System Atrophy
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 94 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
94 participants (actual)

Study arms

  • 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 · Behavioral: behavioral evaluations

  • 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 · Behavioral: behavioral evaluations

  • Experimental
    Controls

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

    Other: MRI acquisition · Behavioral: behavioral evaluations

Interventions

  • OtherMRI acquisition

    MRI acquisitions

  • Behavioralbehavioral evaluations

    Evaluations about motor abilities, sleep, cognition and lifestyle

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What researchers measure

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

07

Study locations

1 site
  • Inserm Umr 825
    Toulouse, 31059, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02428816
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Apr 29, 2015
Start date
Jan 24, 2013
Primary completion
Jul 28, 2016
Completion
Jul 28, 2016
Last update
Feb 9, 2021

Study contacts

Olivier Rascol, Pr
principal investigator · INSERM UMR 825, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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