Imaging Biomarkers in ALS

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02567136

Enrollment

Registered

2015-10-02

Start date

2015-09-30

Completion date

2031-09-30

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

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.

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactValerie Ferment

ferm0016@umn.edu6123011535

Outcome results