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Trial record 28 of 79 for:    "Multiple system atrophy"

Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes (MultiPAMS)

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ClinicalTrials.gov Identifier: NCT02428816
Recruitment Status : Unknown
Verified January 2013 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Active, not recruiting
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Multiple System Atrophy Other: MRI acquisition Behavioral: behavioral evaluations Not Applicable

Detailed Description:
30 patients with PD and 30 patients with MSA 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes
Study Start Date : January 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
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
MRI acquisitions
Behavioral: behavioral evaluations
Evaluations about motor abilities, sleep, cognition and lifestyle
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
MRI acquisitions
Behavioral: behavioral evaluations
Evaluations about motor abilities, sleep, cognition and lifestyle



Primary Outcome Measures :
  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 Outcome Measures :
  1. correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428816


Locations
France
Inserm Umr 825
Toulouse, France, 31059
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Olivier Rascol, Pr INSERM UMR 825, France

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02428816     History of Changes
Other Study ID Numbers: C12-52
2012-A01252-41 ( Registry Identifier: IDRCB )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: January 2013

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
differential diagnosis
multimodal MRI
Parkinson's Disease
Multiple System Atrophy

Additional relevant MeSH terms:
Multiple System Atrophy
Shy-Drager Syndrome
Parkinson Disease
Atrophy
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases