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

NCT ID: NCT02874209

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

sodium MRI

Intervention Type: OTHER

Healthy volunteer

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

Group Type: PLACEBO_COMPARATOR

sodium MRI

Intervention Type: OTHER

Interventions

sodium MRI

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielles DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Aude GRAPPERON, Md

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Masreille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Aude GRAPPERON, MD

Role: CONTACT

aude.grapperon@ap-hm.fr

Facility Contacts

Aude Grapperon, MD

Role: primary

aude.grapperon@ap-hm.fr

Other Identifiers

2015-A00328-41

Identifier Type: OTHER

Identifier Source: secondary_id

2015-15

Identifier Type: -

Identifier Source: org_study_id