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

NCT ID: NCT03039166

Last Updated: 2017-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2022-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

parkinson

Group Type EXPERIMENTAL

MRI 7T

Intervention Type DEVICE

MRI 3 T

Intervention Type DEVICE

partial epilepsy

Group Type EXPERIMENTAL

MRI 7T

Intervention Type DEVICE

MRI 3 T

Intervention Type DEVICE

alzheimer disease

Group Type EXPERIMENTAL

MRI 7T

Intervention Type DEVICE

MRI 3 T

Intervention Type DEVICE

multiple sclerosis

Group Type EXPERIMENTAL

MRI 7T

Intervention Type DEVICE

MRI 3 T

Intervention Type DEVICE

blood sample

Intervention Type BIOLOGICAL

amyotrophic lateral sclerosis

Group Type EXPERIMENTAL

MRI 7T

Intervention Type DEVICE

MRI 3 T

Intervention Type DEVICE

healthy control patients

Group Type ACTIVE_COMPARATOR

MRI 7T

Intervention Type DEVICE

MRI 3 T

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI 7T

Intervention Type DEVICE

MRI 3 T

Intervention Type DEVICE

blood sample

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Catherine GEINDRE

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiatnce Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

maxime GUYE

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ALEXANDRA GIULIANI

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-46

Identifier Type: OTHER

Identifier Source: secondary_id

2016-A01785-46

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prospective Memory Imaging
NCT01638884 UNKNOWN NA
A Study of Imaging in Demyelinating Diseases
NCT05805839 ENROLLING_BY_INVITATION PHASE2
Metabolic Imaging of Neurological Disease
NCT06900244 ENROLLING_BY_INVITATION