Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes

Parkinson's Disease Clinical Trial

— MultiPAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428816
• Other study ID #: C12-52
• Secondary ID: 2012-A01252-41
• Status: Completed
• Phase: N/A
• Start date: January 24, 2013
• Est. completion date: July 28, 2016

Study information

• Verified date: February 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 28, 2016
• Est. primary completion date: July 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders
• Shy-Drager Syndrome

Intervention

Other:
• MRI acquisition
MRI acquisitions

Behavioral:
• behavioral evaluations
Evaluations about motor abilities, sleep, cognition and lifestyle

Locations

Country	Name	City	State
France	Inserm Umr 825	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain		1 year