Imaging Biomarkers in 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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Primary Lateral Sclerosis Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

David Walk, MD

PRINCIPAL_INVESTIGATOR

Valerie Ferment

CONTACT

[email protected]

612-301-1535

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Imaging biomarkers

Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Valerie Ferment

CONTACT

[email protected]

6123011535

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2030
Study completion: 2031
First posted: Oct 2, 2015
Registry last updated: Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting