Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes (MultiPAMS)
Primary Purpose
Parkinson's Disease, Multiple System Atrophy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI acquisition
behavioral evaluations
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease focused on measuring differential diagnosis, multimodal MRI, Parkinson's Disease, Multiple System Atrophy
Eligibility Criteria
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
Sites / Locations
- Inserm Umr 825
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Patients with Parkinson's Disease
Patients with MSA
Controls
Arm Description
Patients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)
Patients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)
30 healthy controls will be submitted to an MRI acquisition and to behavioural evaluations in a sole visit
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain
Full Information
NCT ID
NCT02428816
First Posted
January 28, 2013
Last Updated
February 4, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02428816
Brief Title
Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes
Acronym
MultiPAMS
Official Title
Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2013 (Actual)
Primary Completion Date
July 28, 2016 (Actual)
Study Completion Date
July 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Multiple System Atrophy
Keywords
differential diagnosis, multimodal MRI, Parkinson's Disease, Multiple System Atrophy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Parkinson's Disease
Arm Type
Experimental
Arm Description
Patients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)
Arm Title
Patients with MSA
Arm Type
Experimental
Arm Description
Patients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)
Arm Title
Controls
Arm Type
Experimental
Arm Description
30 healthy controls will be submitted to an MRI acquisition and to behavioural evaluations in a sole visit
Intervention Type
Other
Intervention Name(s)
MRI acquisition
Intervention Description
MRI acquisitions
Intervention Type
Behavioral
Intervention Name(s)
behavioral evaluations
Intervention Description
Evaluations about motor abilities, sleep, cognition and lifestyle
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Rascol, Pr
Organizational Affiliation
INSERM UMR 825, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inserm Umr 825
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes
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