Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
NCT ID: NCT02000713
Last Updated: 2018-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2013-10-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
MRI
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.
Clinical Exam
Brief neurological exam will be performed.
Healthy controls (MRI)
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. Subject participation in this study will be complete following the MRI.
MRI
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.
Interventions
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MRI
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.
Clinical Exam
Brief neurological exam will be performed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Do not have co-morbid psychiatric disease
3. Do not have opportunistic central nervous system infection
4. Do not have cerebrovascular disease
5. Do not have a contraindication for magnetic resonance imaging(MRI)(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
6. Are not pregnant
7. Have not had cervical spinal surgery(neck) -
18 Years
80 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Principal Investigators
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Bradley Foerster, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Hospital
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00069508
Identifier Type: -
Identifier Source: org_study_id
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