Back to resultsCervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Clinical Exam
Sponsored by
About this trial
This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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) -
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amyotrophic Lateral Sclerosis
Healthy controls (MRI)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Study levels of N-acetylaspartate (NAA)in the cervical spinal cord.
1. Study investigators will measure the differences in the spinal cord metabolite, N-acetylaspartate in ALS subjects compared to healthy controls using magnetic spectroscopy.
Secondary Outcome Measures
Fractional anisotropy in the cervical spinal cord
Study fractional anisotropy levels (unitless) using diffusion tensor imaging in ALS patients compared to healthy controls in the cervical spinal cord.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02000713
Brief Title
Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
Official Title
Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Principle Investigator was unable to fulfill responsibilities.
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators want to know if magnetic resonance imaging can accurately provide an early diagnosis of amyotrophic lateral sclerosis (ALS).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amyotrophic Lateral Sclerosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy controls (MRI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Exam
Intervention Description
Brief neurological exam will be performed.
Primary Outcome Measure Information:
Title
Study levels of N-acetylaspartate (NAA)in the cervical spinal cord.
Description
1. Study investigators will measure the differences in the spinal cord metabolite, N-acetylaspartate in ALS subjects compared to healthy controls using magnetic spectroscopy.
Time Frame
60 minutes or as needed (rarely more than 2 hours)
Secondary Outcome Measure Information:
Title
Fractional anisotropy in the cervical spinal cord
Description
Study fractional anisotropy levels (unitless) using diffusion tensor imaging in ALS patients compared to healthy controls in the cervical spinal cord.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Foerster, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
We'll reach out to this number within 24 hrs