NCT03039166

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

January 31, 2017

Last Update Submit

April 13, 2017

Conditions

Diffuse Diseases

Outcome Measures

Primary Outcomes (1)

  • Index of reorganization of the structural hubs (ks-Degree)

    5years

Secondary Outcomes (4)

  • 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

Study Arms (6)

parkinson

EXPERIMENTAL
Device: MRI 7TDevice: MRI 3 T

partial epilepsy

EXPERIMENTAL
Device: MRI 7TDevice: MRI 3 T

alzheimer disease

EXPERIMENTAL
Device: MRI 7TDevice: MRI 3 T

multiple sclerosis

EXPERIMENTAL
Device: MRI 7TDevice: MRI 3 TBiological: blood sample

amyotrophic lateral sclerosis

EXPERIMENTAL
Device: MRI 7TDevice: MRI 3 T

healthy control patients

ACTIVE COMPARATOR
Device: MRI 7TDevice: MRI 3 T

Interventions

MRI 7TDEVICE
alzheimer diseaseamyotrophic lateral sclerosishealthy control patientsmultiple sclerosisparkinsonpartial epilepsy
MRI 3 TDEVICE
alzheimer diseaseamyotrophic lateral sclerosishealthy control patientsmultiple sclerosisparkinsonpartial epilepsy
blood sampleBIOLOGICAL
multiple sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Claustrophobia,
  • Metallic foreign bodies,
  • Pacemakers,
  • Severe renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiatnce Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Catherine GEINDRE

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Central Study Contacts

maxime GUYE

CONTACT

maxime.guye@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 1, 2017

Study Start

May 1, 2017

Primary Completion

February 1, 2022

Study Completion

October 1, 2022

Last Updated

April 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)