| NCT ID | NCT02567136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2015-09 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2015-09 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
David Walk, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT02567136 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02567136 currently recruiting?
Yes, NCT02567136 is actively recruiting participants. Contact the research team at ferm0016@umn.edu for enrollment information.
Where is the NCT02567136 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT02567136 clinical trial?
NCT02567136 is sponsored by University of Minnesota. The principal investigator is David Walk, MD at University of Minnesota. The trial plans to enroll 30 participants.
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