Overview

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

Status:
Recruiting
Trial end date:
2021-09-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
U.S. Army Medical Research Acquisition Activity
United States Department of Defense
Treatments:
Norepinephrine
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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