- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874209
Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis
August 17, 2016 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aude Grapperon, MD
- Email: aude.grapperon@ap-hm.fr
Study Locations
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-
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Masreille, France, 13354
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- Aude Grapperon, MD
- Email: aude.grapperon@ap-hm.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
|
Placebo Comparator: Healthy volunteer
Healthy Volonteer apparied for sexe and age with selected ALS patients will go through the MRI sodium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Central conduction time of the potential muscle through transcranial magnetic stimulation
Time Frame: 4 hours
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Urielles DESALBRES, Assistance Publique Hopitaux de Marseille
- Principal Investigator: Aude GRAPPERON, Md, Assistance Publique Hopitaux de Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
August 17, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 22, 2016
Study Record Updates
Last Update Posted (Estimate)
August 22, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-15
- 2015-A00328-41 (Other Identifier: Ansm)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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