Glymphatic MRI in Clinically Isolated Syndrome

Korábbi kezelés

• 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

Más betegség

• Present psychiatric disorders or severe cognitive deficit
• Past or present history of drug or alcohol abuse
• 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
• Have a history of claustrophobia

Laborértékek

• 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
• 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

Egyéb

• Have a diagnosis of clinically definite Multiple Sclerosis according to the 2017 McDonald's Criteria (Thompson et al., 2018)
• Have a CIS limited to the spinal cord (transverse myelitis)
• Are pregnant or breastfeeding, if females of childbearing potential
• Are taking benzodiazepines on a regular basis or are unable to suspend intake of benzodiazepines
• Are unable to lie down for MRI scanning
• Have any finding on the brain MRI that would compromise subject safety or the scientific integrity of the study
• Have any other contraindication to MRI scanning
• Have a relapse occurred after consent but before the MRI scan

• Male or female, aged 18 or over
• Suitable physically and psychologically to undertake the assessments, as judged by the Investigator
• 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.
• (For CIS group): A diagnosis of CIS or MS at first presentation
• Subjects must not have taken corticosteroids or IVIg or plasma-exchange within the 30 days prior to consent
• Adequate vision and hearing to perform the study procedures
• 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)
• 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).
• 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.