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Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sodium MRI
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Amyotrophic lateral sclerosis patient according to the El Escorial criteria revised Brooks et al. 2000 bulbar or spinal beginning

Exclusion Criteria:

  • patient or healthy volonteer presenting MRI contre indications to this exam.
  • patient or healthy volonteer presenting severe high blood pressure undergoing medication to treat it or not.
  • patient or healthy volonteer having chronic psychiatric illness, dementia

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patient with amyotrophic lateral sclerosis

Healthy volunteer

Arm Description

ALS patients with, spinal and bulbar form, certain or probable diagnosis according to the revised El Escorial criteria will go through the MRI sodium

Healthy Volonteer apparied for sexe and age with selected ALS patients will go through the MRI sodium

Outcomes

Primary Outcome Measures

Central conduction time of the potential muscle through transcranial magnetic stimulation

Secondary Outcome Measures

Full Information

First Posted
August 17, 2016
Last Updated
August 17, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02874209
Brief Title
Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and peripheral motor neurons, characterized by the rapidity of its evolution (median survival of 3 years). The pathophysiology of the disease is still poorly understood. Neuronal death results from several cellular mechanisms entangled, including mitochondrial dysfunction. The absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction causing the accumulation in the sodium and calcium cell causing neuronal death. These studies were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease, stroke and brain tumors. They demonstrated that sodium MRI could be an effective and sensitive biomarker for detecting and quantifying neuronal degeneration. The goal of this study is to assess neuronal damage noninvasively by MRI sodium in amyotrophic lateral sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with amyotrophic lateral sclerosis
Arm Type
Experimental
Arm Description
ALS patients with, spinal and bulbar form, certain or probable diagnosis according to the revised El Escorial criteria will go through the MRI sodium
Arm Title
Healthy volunteer
Arm Type
Placebo Comparator
Arm Description
Healthy Volonteer apparied for sexe and age with selected ALS patients will go through the MRI sodium
Intervention Type
Other
Intervention Name(s)
sodium MRI
Primary Outcome Measure Information:
Title
Central conduction time of the potential muscle through transcranial magnetic stimulation
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Amyotrophic lateral sclerosis patient according to the El Escorial criteria revised Brooks et al. 2000 bulbar or spinal beginning Exclusion Criteria: patient or healthy volonteer presenting MRI contre indications to this exam. patient or healthy volonteer presenting severe high blood pressure undergoing medication to treat it or not. patient or healthy volonteer having chronic psychiatric illness, dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aude GRAPPERON, MD
Email
aude.grapperon@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielles DESALBRES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aude GRAPPERON, Md
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Masreille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude Grapperon, MD
Email
aude.grapperon@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis

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