Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue

Completed · Phase 1/Phase 2

Conditions studied: Multiple Sclerosis

In brief

The overarching aim is to assess the role of microglial activation and norepinephrine transporter binding in pathogenesis of MS-related fatigue, using novel Positron Emission Tomography (PET) radiotracers, \[F-18\]PBR06 and \[C-11\]MRB. Specific Aims: Specific Aim 1: To determine the relationship of cerebral microglial activation, as assessed by \[F-18\]PBR06 PET, with MS-related fatigue. Specific Aim 2: To determine the relationship of norepinephrine transporter (NET) binding, as assessed by \[C-11\]MRB PET, with MS-related fatigue. Specific Aim 3: To determine the relationship of microglial activation and NET binding, with grey matter pathology (lesion load and brain atrophy) assessed using 7T MRI, and evaluate their independent contribution in development of MS-related fatigue.

Key facts

Study ID

NCT04144257

Run by

Brigham and Women's Hospital

People needed

10

Starts

2020-03-12

Expected to finish

2021-04-13

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects meeting the definition for RRMS or SPMS by International Panel (2017 McDonald) Criteria.
• We will recruit patients with RRMS, recently diagnosed in the last 2 years. There will be no disease modifying therapy restrictions for RRMS or SPMS patients.
• Male and female subjects age 18 to 60 years.
• Patients able to withhold medication that may interfere with C-11[MRB] radiotracer uptake for 24 hours before the scan.

You may not qualify if…

• Relapse/Corticosteroid treatment in the past 4 weeks to avoid transient effects on imaging
• Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
• Individuals with bipolar disease and schizophrenia
• Concurrent medical conditions that contraindicate study procedures.
• Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
• Claustrophobia
• Non-MRI compatible implanted devices
• Low affinity binders

Where it is running

• Brigham MS Center, 60 Fenwood Road — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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