Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
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ClinicalTrials.gov Identifier: NCT02000713 |
Recruitment Status :
Terminated
(Principle Investigator was unable to fulfill responsibilities.)
First Posted : December 4, 2013
Last Update Posted : June 4, 2018
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Condition or disease | Intervention/treatment | Phase |
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Amyotrophic Lateral Sclerosis | Other: MRI Other: Clinical Exam | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS) |
Study Start Date : | October 2013 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
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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.
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Other: 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. Other: Clinical Exam Brief neurological exam will be performed. |
Active Comparator: 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.
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Other: 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. |
- Study levels of N-acetylaspartate (NAA)in the cervical spinal cord. [ Time Frame: 60 minutes or as needed (rarely more than 2 hours) ]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 ]Study fractional anisotropy levels (unitless) using diffusion tensor imaging in ALS patients compared to healthy controls in the cervical spinal cord.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Adults age 18 to 80 years of age.
Exclusion Criteria:
- Do not have active substance abuse
- Do not have co-morbid psychiatric disease
- Do not have opportunistic central nervous system infection
- Do not have cerebrovascular disease
- Do not have a contraindication for magnetic resonance imaging(MRI)(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
- Are not pregnant
- Have not had cervical spinal surgery(neck) -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000713
United States, Michigan | |
University of Michigan Hospital | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Bradley Foerster, M.D. | University of Michigan Hospital |
Responsible Party: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT02000713 |
Other Study ID Numbers: |
HUM00069508 |
First Posted: | December 4, 2013 Key Record Dates |
Last Update Posted: | June 4, 2018 |
Last Verified: | May 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |