Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
The investigators are wanting to know if magnetic resonance imaging can accurately provide an early diagnosis of amyotrophic lateral sclerosis (ALS).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)|
- Study levels of N-acetylaspartate (NAA)in the cervical spinal cord. [ Time Frame: 3 years ] [ Designated as safety issue: No ]1. Study investigators will measure the differences in the spinal cord metabolite, N-acetylaspartate in ALS subjects compared to healthy controls using magnetic spectroscopy.
- Fractional anisotropy in the cervical spinal cord [ Time Frame: 3 years ] [ Designated as safety issue: No ]Study fractional anisotropy levels (unitless) using diffusion tensor imaging in ALS patients compared to healthy controls in the cervical spinal cord.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: Amyotrophic Lateral Sclerosis
All subjects will be interviewed and administered a brief questionnaire to determine current disease severity. A brief neurological examination will be given to determine reflexes. Subjects will also have magnetic resonance imaging(MRI)scans of the cervical spine(neck). Women of child-bearing potential will need to have a urine pregnancy test immediately prior to the MRI scan. Mri scan will take approximately 60 minutes to complete. The clinical examinations will take approximately 30 minutes to complete. Subject participation in this study will be complete following the MRI and clinical examinations.
Procedure: Amyotrophic Lateral Sclerosis
Subjects will have magnetic resonance imaging(MRI)scans of the cervical spine(neck). This involves lying on a table and sliding into a scanner consisting of a large magnet. This will take approximately one hour to complete. All subjects will be instructed to remove all jewelry and other metal-containing objects for the scan. During the MRI scan loud noises may be heard. Subjects may have a soft brace for the neck for positioning purposes.
Currently there is no definitive diagnostic test for amyotrophic lateral sclerosis (ALS). The investigators goal is to determine if magnetic resonance imaging can provide an accurate diagnosis of ALS by looking at chemical concentrations in the spinal cord at the neck level which show up in MRI imaging and compare these chemical concentrations to corresponding measures in healthy control subjects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02000713
|Contact: Bradley Foerster, M.D.||734-615-3586|
|Contact: Ladonna Austin, CCRCfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Bradley Foerster, M.D. 734-615-3586|
|Contact: Ladonna Austin, CCRC 734-936-8275 email@example.com|
|Principal Investigator: Bradley Foerster, M.D.|
|Principal Investigator:||Bradley Foerster, M.D.||University of Michigan Hospital|