MRI markers for ALS and PLS
A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
The study will use 3T and 7T MRI scans to see if specific brain imaging markers differ between people with ALS or PLS and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT02567136 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults with ALS, PLS, and healthy controls to undergo MRI scanning at 3 tesla and 7 tesla to search for imaging biomarkers. Participants receive standardized MRI protocols to capture structural and functional brain measures that may correlate with disease presence or severity. Imaging findings will be compared across diagnostic groups and linked to clinical status to identify reproducible markers. Scans require participants to tolerate extended time in the scanner and exclude those with standard MRI contraindications.
Who should consider this trial
Good fit: Adults aged 21–75 with a clinical diagnosis of possible, probable, or definite ALS (or PLS) who can give informed consent and tolerate MRI scanning are ideal candidates.
Not a fit: Patients with other neurodegenerative diagnoses, those unable to undergo MRI (for example due to pacemakers, metal implants, claustrophobia, or weight over 300 lbs), or those who require assistance to ambulate are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, identified MRI biomarkers could enable earlier detection, more precise tracking of disease progression, and improved selection and monitoring in treatment studies.
How similar studies have performed: Previous MRI research in ALS has shown promising but not yet definitive imaging changes, so this study builds on prior partial successes to seek reproducible biomarkers.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: David Walk, MD — University of Minnesota
- Study coordinator: Valerie Ferment
- Email: ferm0016@umn.edu
- Phone: 6123011535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.