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

This study is not yet open for participant recruitment.
Verified April 2017 by Assistance Publique Hopitaux De Marseille
Sponsor:
ClinicalTrials.gov Identifier:
NCT03039166
First Posted: February 1, 2017
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  Purpose

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.


Condition Intervention
Diffuse Diseases Device: MRI 7T Device: MRI 3 T Biological: blood sample

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Index of reorganization of the structural hubs (ks-Degree) [ Time Frame: 5years ]

Secondary Outcome Measures:
  • Concentrations of sodium within hubs [ Time Frame: 5 years ]
  • Concentrations of Glutamate/Glutamine within hubs [ Time Frame: 5 years ]
  • cortical Thicknesses within hubs [ Time Frame: 5 years ]
  • Iron accumulation within hubs [ Time Frame: 5 years ]

Estimated Enrollment: 260
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Device: MRI 7T Device: MRI 3 T Biological: blood sample
Experimental: amyotrophic lateral sclerosis Device: MRI 7T Device: MRI 3 T
Active Comparator: healthy control patients Device: MRI 7T Device: MRI 3 T

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039166


Contacts
Contact: maxime GUYE maxime.guye@ap-hm.fr

Locations
France
Assiatnce Publique Hopitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: ALEXANDRA GIULIANI       drci@ap-hm.fr   
Principal Investigator: MAXIME GUYE         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Catherine GEINDRE Assistance Publique Hopitaux De Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03039166     History of Changes
Other Study ID Numbers: 2016-A01785-46
2016-46 ( Other Identifier: Assistance Publique-Hôpitaux de Marseille )
First Submitted: January 31, 2017
First Posted: February 1, 2017
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nervous System Diseases