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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 : November 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
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


Groups and Cohorts

Group/Cohort
Amyotrophic Lateral Sclerosis
Patients with ALS
Healthy Controls
Healthy control volunteers


Outcome Measures

Primary Outcome Measures :
  1. Imaging biomarkers [ Time Frame: 12 months ]
    Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: David Walk, MD University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02567136     History of Changes
Other Study ID Numbers: 130126
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases