Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI
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|ClinicalTrials.gov Identifier: NCT03039166|
Recruitment Status : Not yet recruiting
First Posted : February 1, 2017
Last Update Posted : April 14, 2017
the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on functional dysfunction not directly related to each disease, but that could induce common syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.
The objective here is to test this hypothesis and provides better understandings on pathophysiological processes affecting those highly connected regions in 'diffuse' and 'focal' neurological diseases.
The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS, cognitive rehabilitation ...).
Practically, the investigators will explore 200 patients classified in 5 cohorts of 40 patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to assess structural and functional brain connectivity implemented on the human 7T MR scanner equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).
In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium) mapping will complement the MR protocol to characterize the pathophysiological processes of hub injury. Sixty healthy controls will also be explored wih the same protocol for normal database.
The proposal aims at characterizing and comparing from a morphological-functional point of view, the hub regions of patients suffering from these five diseases, to demonstrate the pertinence to preserve hub integrity as a major therapeutic target whatever the disease.
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Diseases||Device: MRI 7T Device: MRI 3 T Biological: blood sample||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI|
|Estimated Study Start Date :||May 2017|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||October 2022|
|Experimental: parkinson||Device: MRI 7T Device: MRI 3 T|
|Experimental: partial epilepsy||Device: MRI 7T Device: MRI 3 T|
|Experimental: alzheimer disease||Device: MRI 7T Device: MRI 3 T|
|Experimental: multiple sclerosis||Device: MRI 7T Device: MRI 3 T Biological: blood sample|
|Experimental: amyotrophic lateral sclerosis||Device: MRI 7T Device: MRI 3 T|
|Active Comparator: healthy control patients||Device: MRI 7T Device: MRI 3 T|
- Index of reorganization of the structural hubs (ks-Degree) [ Time Frame: 5years ]
- Concentrations of sodium within hubs [ Time Frame: 5 years ]
- Concentrations of Glutamate/Glutamine within hubs [ Time Frame: 5 years ]
- cortical Thicknesses within hubs [ Time Frame: 5 years ]
- Iron accumulation within hubs [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039166
|Contact: maxime GUYEemail@example.com|
|Assiatnce Publique Hopitaux de Marseille||Not yet recruiting|
|Marseille, France, 13354|
|Contact: ALEXANDRA GIULIANI firstname.lastname@example.org|
|Principal Investigator: MAXIME GUYE|
|Study Director:||Catherine GEINDRE||Assistance Publique Hopitaux De Marseille|