- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02567136
Imaging Biomarkers in ALS
March 25, 2024 updated by: University of Minnesota
A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
The purpose of the study is to determine if we are able to find one or more biomarkers of Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T).
A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state.
Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments.
This study will enroll patients with ALS, PLS, and healthy controls.
Study Overview
Status
Active, not recruiting
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study will enroll ALS patients seeking care at the University of Minnesota and age-matched healthy control volunteers.
Description
Inclusion Criteria:
- 21 to 75 years of age inclusive.
- Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
ALS patients:
- A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria.
Exclusion Criteria:
- Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
- Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
- Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes.
- The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Amyotrophic Lateral Sclerosis
Patients with ALS
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Healthy Controls
Healthy control volunteers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging biomarkers
Time Frame: 12 months
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Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Walk, MD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
September 30, 2015
First Submitted That Met QC Criteria
October 1, 2015
First Posted (Estimated)
October 2, 2015
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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