Neuroimaging for Chronic Fatigue Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the brain processes unpleasant sensations, such as pain and effort, in individuals with chronic fatigue syndrome (ME/CFS) and healthy volunteers. By using advanced brain imaging techniques (functional neuroimaging), researchers aim to understand why some individuals experience heightened responses to these sensations. Participants will perform tasks involving heat and physical exertion while researchers monitor their brain activity. Individuals diagnosed with ME/CFS or healthy individuals aged 18 to 50 may be suitable for this study. As an Early Phase 1 trial, this study focuses on understanding how the brain processes these sensations, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires that you do not use certain medications, such as psychomotor stimulants, antipsychotics, benzodiazepines, and opioids. If you are taking these, you may need to stop before participating.
What prior data suggests that this neuroimaging technique is safe for participants?
Research has shown that using MRI scans to study brain activity is generally safe for conditions like chronic fatigue syndrome (CFS). Some studies have used MRI to examine brain activity in people with CFS and found it can safely highlight differences in brain function compared to healthy individuals.
These imaging techniques are commonly used for other health conditions and are non-invasive, meaning they don't involve surgery or entering the body. No reports of serious side effects have emerged from using MRI in these studies. Participants might feel uncomfortable lying still in the machine, but this is normal and not harmful.
This trial is in an early stage, primarily focusing on ensuring safety. Researchers will closely monitor participants for any possible issues. Overall, research has shown that using MRI to study brain processes is safe and well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about using functional neuroimaging for Chronic Fatigue Syndrome (CFS) because it offers a fresh perspective on understanding this complex condition. Unlike traditional treatments for CFS, which often focus on managing symptoms with medication or lifestyle changes, functional neuroimaging allows scientists to see how the brain functions in real time. This technique could uncover specific brain patterns or abnormalities linked to CFS, potentially leading to more targeted and effective treatments in the future. By visualizing brain activity, researchers hope to identify precise markers of the syndrome, which could revolutionize diagnosis and treatment strategies.
What evidence suggests that functional neuroimaging is effective for studying ME/CFS?
Research has shown that brain scans, such as those used in functional neuroimaging, reveal differences in the brains of people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Studies have found that during mental tasks, people with ME/CFS often engage more brain areas compared to healthy individuals. Other research has identified unusual features in the brain stem and changes in brain structure, including the amount of gray and white matter. These findings suggest that brain scans can help identify unique brain patterns in ME/CFS, potentially related to symptoms like tiredness and pain. Although direct evidence linking these findings to effective treatments is limited, understanding these brain changes could aid in developing future therapies. This trial will use functional neuroimaging to further explore these brain patterns in a single-arm study.23678
Who Is on the Research Team?
Eric M Wassermann, M.D.
Principal Investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Are You a Good Fit for This Trial?
This trial is for people aged 18 to 50 who have ME/CFS or are healthy volunteers. It involves three visits over a few weeks, where participants will undergo MRI scans and perform tasks that measure their response to pain from heat and the effort of squeezing a bar.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Mock MRI and Task Practice
Participants undergo a mock MRI scan and practice thermal pain and physical effort tasks
Real MRI and Task Execution
Participants undergo real MRI scans and perform thermal pain and physical effort tasks
Follow-up
Participants are monitored for safety and effectiveness after the MRI sessions
What Are the Treatments Tested in This Trial?
Interventions
- Functional Neuroimaging
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Neurological Disorders and Stroke (NINDS)
Lead Sponsor