Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI

Not Applicable

• Conditions: Diffuse Diseases
• Interventions: Device: MRI 7T; Device: MRI 3 T; Biological: blood sample

• Registration Number: NCT03039166
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14
• Study Start: 2017-05
• Primary Completion: 2022-02
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parkinson	MRI 7T	-
parkinson	MRI 3 T	-
alzheimer disease	MRI 3 T	-
multiple sclerosis	MRI 7T	-
multiple sclerosis	blood sample	-
amyotrophic lateral sclerosis	MRI 7T	-
amyotrophic lateral sclerosis	MRI 3 T	-
partial epilepsy	MRI 7T	-
alzheimer disease	MRI 7T	-
multiple sclerosis	MRI 3 T	-
partial epilepsy	MRI 3 T	-
healthy control patients	MRI 7T	-
healthy control patients	MRI 3 T	-

Primary Outcome Measures

Name	Time	Method
Index of reorganization of the structural hubs (ks-Degree)	5years

Secondary Outcome Measures

Name	Time	Method
Concentrations of sodium within hubs	5 years
Concentrations of Glutamate/Glutamine within hubs	5 years
Iron accumulation within hubs	5 years
cortical Thicknesses within hubs	5 years

Trial Locations

Locations (1)

Assiatnce Publique Hopitaux de Marseille; 🇫🇷 Marseille, France