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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Diffuse Diseases

Treatments

Device: MRI 3 T
Biological: blood sample
Device: MRI 7T

Study type

Interventional

Funder types

Other

Identifiers

NCT03039166
2016-46 (Other Identifier)
2016-A01785-46

Details and patient eligibility

About

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.

Enrollment

260 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

260 participants in 6 patient groups

parkinson
Experimental group
Treatment:
Device: MRI 3 T
Device: MRI 7T
partial epilepsy
Experimental group
Treatment:
Device: MRI 3 T
Device: MRI 7T
alzheimer disease
Experimental group
Treatment:
Device: MRI 3 T
Device: MRI 7T
multiple sclerosis
Experimental group
Treatment:
Device: MRI 3 T
Device: MRI 7T
Biological: blood sample
amyotrophic lateral sclerosis
Experimental group
Treatment:
Device: MRI 3 T
Device: MRI 7T
healthy control patients
Active Comparator group
Treatment:
Device: MRI 3 T
Device: MRI 7T

Trial contacts and locations

1

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Central trial contact

maxime GUYE

Data sourced from clinicaltrials.gov

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