Clinical trial Recruiting at 1 site Observational Ages 21 to 75

MRI markers for ALS and PLS

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

Run by University of Minnesota · NCT02567136 · Data updated 2026-11-12

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 typeObservational
Ages21 Years to 75 Years
SexAll
Enrollment30 (estimated)
SponsorUniversity of Minnesota
Academic / other
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedSeptember 2015
Main results expectedSeptember 30, 2030
Study endsSeptember 30, 2031
Registry record updatedDecember 2, 2025
Trial IDNCT02567136 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.