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Imaging Biomarkers in ALS

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02567136
Collaborator
(none)
30
Enrollment
1
Location
120
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Sep 1, 2015
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Sep 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Amyotrophic Lateral Sclerosis

    Patients with ALS
    Healthy Controls

    Healthy control volunteers

    Outcome Measures

    Primary Outcome Measures

    1. Imaging biomarkers [12 months]

      Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55414

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: David Walk, MD, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT02567136
    Other Study ID Numbers:
    • 130126
    First Posted:
    Oct 2, 2015
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Mar 15, 2022