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

Study Purpose:

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 Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis , Primary Lateral Sclerosis

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

David Walk, MD, University of Minnesota

Clinicaltrials.gov ID:

NCT02567136

Neals Affiliated?

No

Coordinating Center Contact Information

University of Minnesota

Minneapolis, Minnesota, 55414 United States

Full Study 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.

Study Sponsor:

University of Minnesota

Estimated Enrollment:

30

Estimated Study Start Date:

08 / 31 / 2015

Estimated Study Completion Date:

09 / 01 / 2025

Posting Last Modified Date:

03 / 15 / 2022

Date Study Added to neals.org:

10 / 02 / 2015

Primary Outcome Measures:
Imaging biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.

https://clinicalt...CT02567136&rank=1

Minimum Age:

21 Years

Maximum Age:

75 Years

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.

University of Minnesota

Minneapolis, Minnesota 55414
United States