Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

  • Study type:

    Observational What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 11-003982
  • NCT ID:

    NCT01396343
  • Sponsor Protocol Number:

    NPMSC 002

About this study

The purpose of this study is to better understand multiple sclerosis (MS) in children and adolescents, to learn if it differs from adult MS and to investigate if genes or environmental exposures or a combination of both put children and adolescents at risk for getting MS.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Children are eligible for this study as cases if:

  • They have MS or clinically isolated syndrome (CIS):
    • MS: As defined by the 2010 McDonald criteria for diagnosis of MS (Polman 2010),
    • CIS: A first demyelinating event indicating high risk for MS (i.e., one clinical event involving the spinal cord, the optic nerve, the brainstem or cerebellum, or occasionally the hemispheres) and at least 2 silent T2 bright areas on a brain or spinal cord MRI (at least one must be in the brain); AND
  • They are three years of age or older; AND
  • Disease onset occurred before 18 years of age.

Patients are not eligible for study participation if:

  • Disease onset occurred more than 4 years prior to the opportunity to enroll; OR
  • They have had an organ transplant; OR
  • They are known to have neuromyelitis optica (NMO).

Children are not eligible to participate as pediatric controls if:

  • They are two years of age or younger; OR
  • They are 22 years of age or older; OR
  • They are known to have MS or another demyelinating disease (for example, neuromyelitis optica or acute disseminated encephalomyelitis); OR
  • They have a biological family member who has been enrolled as a control; OR
  • They have an immediate, biological family member (parent/sibling) who has been diagnosed with MS; OR
  • They have an autoimmune disorder (except asthma or eczema); OR
  • They have had an organ transplant; OR
  • They have a chronic neurological condition with major disability (this does not include, for example, migraine, controlled seizures, and mild learning disabilities such as ADD or ADHD).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jan-Mendelt Tillema, M.D.

Open for enrollment

Jaime Sorum

(507)538-5418

Sorum.Jaime@mayo.edu