ALS Therapy Development Institute

Imaging Biomarkers in ALS

Imaging Biomarkers in ALS

Quick Info:

Status:
Ongoing, But Not Recruiting
Estimated Enrollment:
30
Phase:
Treatment Type:
MRI
Trial Type:
Observational Model: Case Control
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Primary Investigator:
Contact Information:

Trial Goal:
Tests to Expect:

Update Notes:

5/2/2018No significant updates
2/13/2018No significant updates
11/9/2017No significant updates
6/19/2017No significant updates
11/28/2016Recruitment status updated
5/18/2016No significant updates.
10/8/2015Clinical trial added.

Locations:

University of Minnesota, Minneapolis, 55414

Other Information:

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.
Eligibility: 21 to 75 years old, All genders, Accepting healthy volunteers
Details: Inclusion Criteria: -Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB). 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. This study will enroll ALS patients seeking care at the University of Minnesota and age-matched healthy control volunteers.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 9/30/2015
ClinicalTrials.gov ID: NCT02567136
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov