Imaging Biomarkers in ALS

A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Valerie Ferment; Phone Number: 6123011535; Email: ferm0016@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Valerie Ferment; Phone Number: 612-301-1535; Email: ferm0016@umn.edu
      • Principal Investigator: David Walk, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: CASE_CONTROL
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging biomarkers	Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimated): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Nutritional and Metabolic Diseases; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 130126