Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT02567136

Conditions

Amyotrophic Lateral Sclerosis

Primary Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Amyotrophic Lateral Sclerosis

Primary Lateral Sclerosis

Study ID

NCT02567136

Start date

Sep, 2015

Status verified date

Nov, 2025

Completion date

Sep 30, 2031

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Amyotrophic Lateral Sclerosis

Patients with ALS

Healthy Controls

Healthy control volunteers

Primary outcome measure

  • Imaging biomarkers [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Valerie Ferment

6123011535ferm0016@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Valerie Ferment

612-301-1535ferm0016@umn.edu

Principal Investigator:

David Walk, MD

More Information

Sponsor

University of Minnesota

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-12-02.