Imaging Biomarkers in ALS
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|ClinicalTrials.gov Identifier: NCT02567136|
Recruitment Status : Active, not recruiting
First Posted : October 2, 2015
Last Update Posted : March 22, 2023
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|Condition or disease|
|Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2025|
|Estimated Study Completion Date :||September 2025|
Amyotrophic Lateral Sclerosis
Patients with ALS
Healthy control volunteers
- Imaging biomarkers [ Time Frame: 12 months ]Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.
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|Ages Eligible for Study:||21 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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).
- A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial 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.
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): NCT02567136
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||David Walk, MD||University of Minnesota|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||October 2, 2015 Key Record Dates|
|Last Update Posted:||March 22, 2023|
|Last Verified:||March 2023|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases