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

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ClinicalTrials.gov Identifier: NCT02874209
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: sodium MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: Patient with amyotrophic lateral sclerosis
ALS patients with, spinal and bulbar form, certain or probable diagnosis according to the revised El Escorial criteria will go through the MRI sodium
Other: sodium MRI
Placebo Comparator: Healthy volunteer
Healthy Volonteer apparied for sexe and age with selected ALS patients will go through the MRI sodium
Other: sodium MRI



Primary Outcome Measures :
  1. Central conduction time of the potential muscle through transcranial magnetic stimulation [ Time Frame: 4 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02874209


Contacts
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Contact: Aude GRAPPERON, MD aude.grapperon@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Masreille, France, 13354
Contact: Aude Grapperon, MD       aude.grapperon@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielles DESALBRES Assistance Publique Hopitaux De Marseille
Principal Investigator: Aude GRAPPERON, Md Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02874209     History of Changes
Other Study ID Numbers: 2015-15
2015-A00328-41 ( Other Identifier: Ansm )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases