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Imaging Biomarkers in ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567136
Recruitment Status : Active, not recruiting
First Posted : October 2, 2015
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date September 30, 2015
First Posted Date October 2, 2015
Last Update Posted Date March 22, 2023
Study Start Date September 2015
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2015)		 Imaging biomarkers [ Time Frame: 12 months ]
Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Imaging Biomarkers in ALS
Official Title A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Amyotrophic Lateral Sclerosis
  • Primary Lateral Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • Amyotrophic Lateral Sclerosis
    Patients with ALS
  • Healthy Controls
    Healthy control volunteers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 1, 2015)		 30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02567136
Other Study ID Numbers 130126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor University of Minnesota
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: David Walk, MD University of Minnesota
PRS Account University of Minnesota
Verification Date March 2023