Glymphatic MRI in Clinically Isolated Syndrome

Launched by UNIVERSITY OF EXETER · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a brain system called the Glymphatic System, which helps remove waste from the brain. Researchers believe that if this system isn't working properly, it may contribute to inflammation and cell damage in conditions like Multiple Sclerosis (MS). The trial specifically focuses on patients with Clinically Isolated Syndrome (CIS), which can be an early sign of MS. By using a special type of MRI scan, the researchers hope to find out if problems with this waste removal system are linked to symptoms and blood changes in patients with CIS.

To participate in this study, you need to be at least 18 years old and have a diagnosis of CIS or MS. You should also be in good health, meaning no major medical issues except for CIS. Participants will undergo MRI scans and provide information about their health. It's important to note that some people may not qualify, such as those with certain medical conditions or those who have recently started specific treatments. If successful, this research could lead to larger studies that could help us better understand and treat MS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, aged 18 or over
• • 2. Suitable physically and psychologically to undertake the assessments, as judged by the Investigator
• • 3. Have voluntarily provided informed consent and have signed an ICF indicating that the purpose of the study has been explained and are willing and able to adhere to the study procedures described in the ICF.
• • 4. (For CIS group): A diagnosis of CIS or MS at first presentation
• • 5. Subjects must not have taken corticosteroids or IVIg or plasma-exchange within the 30 days prior to consent
• • 6. Adequate vision and hearing to perform the study procedures
• • 7. Medically healthy with no clinically significant findings on physical examination, laboratory profiles, vital signs at screening (with the exception of the signs of the condition under investigation)
• • 8. Women of child-bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, or double-barrier method (condom or intrauterine device with spermicide).
• • 9. If on immunomodulatory medication, patients must have started it at least 30 days from screening and should not change their medication dose for the duration of the study.
• Exclusion Criteria:
• • 1. Have a diagnosis of clinically definite Multiple Sclerosis according to the 2017 McDonald's Criteria (Thompson et al., 2018)
• • 2. Have a CIS limited to the spinal cord (transverse myelitis)
• • 3. Present psychiatric disorders or severe cognitive deficit
• • 4. Past or present history of drug or alcohol abuse
• • 5. Are pregnant or breastfeeding, if females of childbearing potential
• • 6. Have any other medical, neurological, or psychiatric condition or clinically significant laboratory abnormality excluding CIS which, in the opinion of the Investigator, might preclude participation
• • 7. Are taking benzodiazepines on a regular basis or are unable to suspend intake of benzodiazepines
• • 8. Have received any investigational product within a time-period equal to five half-lives of the product, if known, or minimum of 60 days before consent
• • 9. Are unable to lie down for MRI scanning
• • 10. Have any finding on the brain MRI that would compromise subject safety or the scientific integrity of the study
• • 11. Have implants, such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, aneurysm clips, or other medical implants that have not been deemed safe for MRI
• • 12. Have a history of claustrophobia
• • 13. Have any other contraindication to MRI scanning
• • 14. Have a relapse occurred after consent but before the MRI scan
• • 15. It is preferable the following laboratory tests are part of the subject's medical history for differential diagnosis of clinically isolated syndrome (CIS): erythrocyte sedimentation rate (ESR), antinuclear antibody (ANA), complement (C3, C4) and anticardiolipin IgG - IgM