Clinical trial NCT03039166: Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI
Official title: Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diffuse Diseases
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Person female or male, more than 18-year-old,
* Person presenting unchecked general disease such as severe cancer, autoimmune disease, hepatic insufficiency, severe or untreated, shady arterial high blood pressure of the conduction or the disorder of the rhythm
* Person presenting chronic psychiatric disease, insane syndrome.
* Person presenting contraindication to the realization of an examination by MRI (metallic claustrophobia, foreign body, pacemakers),
* Person benefiting from a social security cover,
* Person having read, understood and signed an informed consent after information

Exclusion Criteria:

* Claustrophobia,
* Metallic foreign bodies,
* Pacemakers,
* Severe renal insufficiency

Primary outcomes:
measure: Index of reorganization of the structural hubs (ks-Degree)
timeFrame: 5years
Secondary outcomes:
measure: Concentrations of sodium within hubs
timeFrame: 5 years
measure: Concentrations of Glutamate/Glutamine within hubs
timeFrame: 5 years
measure: cortical Thicknesses within hubs
timeFrame: 5 years
measure: Iron accumulation within hubs
timeFrame: 5 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assiatnce Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References: