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

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.

Study Overview

• Status: Unknown
• Conditions: Diffuse Diseases
• Intervention / Treatment: Biological: blood sample; Device: MRI 7T; Device: MRI 3 T

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assiatnce Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Biological: blood sample; Device: MRI 7T; Device: MRI 3 T
EXPERIMENTAL: amyotrophic lateral sclerosis	Device: MRI 7T; Device: MRI 3 T
ACTIVE_COMPARATOR: healthy control patients	Device: MRI 7T; Device: MRI 3 T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Index of reorganization of the structural hubs (ks-Degree)	5years

Secondary Outcome Measures

Outcome Measure	Time Frame
Concentrations of sodium within hubs	5 years
Concentrations of Glutamate/Glutamine within hubs	5 years
cortical Thicknesses within hubs	5 years
Iron accumulation within hubs	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2017
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (ESTIMATE): February 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2016-A01785-46; 2016-46 (OTHER: Assistance Publique-Hôpitaux de Marseille)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No