Back to resultsTherapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional other trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Subjects with amyotrophic lateral sclerosis -
Exclusion Criteria:
- Do not have opportunistic central nervous system infection
- Do not have a history of head injury
- Do not have cerebrovascular disease
- Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
- Must not be pregnant -
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ALS patients receivng stem cells
ALS patients not receiving stem cells
Arm Description
Amyotrophic lateral sclerosis(ALS)subjects, who will be receiving stem cells, will undergo a brief clinical evaluation and questionnaire that will last approximately 20 to 30 min. Subjects will be asked to undergo magnetic resonance imaging(MRI)scans of the cervical spine and brain that will last approximately 60 minutes.
Amyotrophic lateral sclerosis(ALS)patient who will not be receiving stem cells, will have an MRI that lasts approximately 60 minutes. This MRI will be repeated at three different time points. Subjects will have an initial MRI, then another at both 6 and 12 months after the initial magnetic resonance imaging(MRI)scan. Subjects will also complete a clinical examination which will take approximately 30 minutes for each MRI. The follow-up magnetic resonance imaging(MRI)scans done for ALS patients who do not receive stem cells are part of routine clinical studies and therefore subjects will not be billed.
Outcomes
Primary Outcome Measures
Changes in spinal cord metabolites in treated ALS subjects and nontreated ALS subjects.
1. The longitudinal changes in spinal cord metabolites in amyotrophic lateral sclerosis(ALS) stem cell treated patients will be compared to amyotrophic lateral sclerosis(ALS) non-treated patients using magnetic resonance spectroscopy. Investigators hypothesize that amyotrophic lateral sclerosis(ALS) stem cell treated patients will demonstrate attenuated rates of decline in the levels of N-acetylaspartate(NAA), a measure of neuronal integrity, in the cervical spinal cord than amyotrophic lateral sclerosis(ALS) non-treated patients.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02058732
Brief Title
Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
Official Title
Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator was unable to fulfill his responsibilities.
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
September 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study the cervical spinal cord and brain over time to assess changes and differences in subjects with amyotrophic lateral sclerosis.
Detailed Description
Investigators will study cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant compared to ALS patients who have not had a stem cell transplant. Investigators intend to determine cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant and compare these to corresponding measures in amyotrophic lateral sclerosis(ALS) patients who have not had a stem cell transplant.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALS patients receivng stem cells
Arm Type
Active Comparator
Arm Description
Amyotrophic lateral sclerosis(ALS)subjects, who will be receiving stem cells, will undergo a brief clinical evaluation and questionnaire that will last approximately 20 to 30 min. Subjects will be asked to undergo magnetic resonance imaging(MRI)scans of the cervical spine and brain that will last approximately 60 minutes.
Arm Title
ALS patients not receiving stem cells
Arm Type
Active Comparator
Arm Description
Amyotrophic lateral sclerosis(ALS)patient who will not be receiving stem cells, will have an MRI that lasts approximately 60 minutes. This MRI will be repeated at three different time points. Subjects will have an initial MRI, then another at both 6 and 12 months after the initial magnetic resonance imaging(MRI)scan. Subjects will also complete a clinical examination which will take approximately 30 minutes for each MRI. The follow-up magnetic resonance imaging(MRI)scans done for ALS patients who do not receive stem cells are part of routine clinical studies and therefore subjects will not be billed.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells. This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
Primary Outcome Measure Information:
Title
Changes in spinal cord metabolites in treated ALS subjects and nontreated ALS subjects.
Description
1. The longitudinal changes in spinal cord metabolites in amyotrophic lateral sclerosis(ALS) stem cell treated patients will be compared to amyotrophic lateral sclerosis(ALS) non-treated patients using magnetic resonance spectroscopy. Investigators hypothesize that amyotrophic lateral sclerosis(ALS) stem cell treated patients will demonstrate attenuated rates of decline in the levels of N-acetylaspartate(NAA), a measure of neuronal integrity, in the cervical spinal cord than amyotrophic lateral sclerosis(ALS) non-treated patients.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Subjects with amyotrophic lateral sclerosis -
Exclusion Criteria:
Do not have opportunistic central nervous system infection
Do not have a history of head injury
Do not have cerebrovascular disease
Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
Must not be pregnant -
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
Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
We'll reach out to this number within 24 hrs