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

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: sodium MRI

• Registration Number: NCT02874209
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-22
• Last Update Posted: 2016-08-22
• Primary Completion: 2017-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	sodium MRI	Healthy Volonteer apparied for sexe and age with selected ALS patients will go through the MRI sodium
Patient with amyotrophic lateral sclerosis	sodium MRI	ALS patients with, spinal and bulbar form, certain or probable diagnosis according to the revised El Escorial criteria will go through the MRI sodium

Primary Outcome Measures

Name	Time	Method
Central conduction time of the potential muscle through transcranial magnetic stimulation	4 hours

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Masreille, France