Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-… (NCT04144257) | Clinical Trial Compass
CompletedPhase 1/2
Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue
United States10 participantsStarted 2020-03-12
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.