Diffuse Diseases Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 260 |
| Est. completion date | October 2022 |
| Est. primary completion date | February 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assiatnce Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Index of reorganization of the structural hubs (ks-Degree) | 5years | ||
| Secondary | Concentrations of sodium within hubs | 5 years | ||
| Secondary | Concentrations of Glutamate/Glutamine within hubs | 5 years | ||
| Secondary | cortical Thicknesses within hubs | 5 years | ||
| Secondary | Iron accumulation within hubs | 5 years |