Glymphatic MRI in Clinically Isolated Syndrome

Last updated: July 11, 2024
Sponsor: University of Exeter
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Magnetic Resonance Imaging

Clinical Study ID

NCT06274671
23-24-09
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The brain possesses a system to get rid of unwanted substances, named Glymphatic System (GS). When this system is faulty, these accumulate, there is local inflammation, and progressive death of the cells. This occurs in neurological diseases including Parkinson's, or Alzheimer's. Inflammation and progressive death of the cells are also present in another neurological disorder, named Multiple Sclerosis (MS).

Doctors think that GS dysfunction plays a role in MS too. In this research therefore, the aim is to study whether it drives inflammation, and disease progression in MS patients.

The researchers have developed a new way to find signs of alteration of the GS using a scan named Magnetic Resonance Imaging (MRI) and will use it in a pilot study on patients with a condition named Clinically Isolated Syndrome (CIS), which often represents the very beginning of MS. It would therefore be demonstrated that the GS is a new mechanism of disease in CIS, which may associate with the symptoms, or the alterations in the levels of some substances in the blood suggestive of brain cells damage.

Should this study be successful, this would provide preliminary evidence to perform a larger research study to assess if GS dysfunction drives the progression of MS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, aged 18 or over

  2. Suitable physically and psychologically to undertake the assessments, as judged bythe Investigator

  3. Have voluntarily provided informed consent and have signed an ICF indicating thatthe purpose of the study has been explained and are willing and able to adhere tothe 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 ofthe condition under investigation)

  8. Women of child-bearing potential must practice a medically acceptable method ofbirth control. Acceptable methods include oral contraceptive, contraceptive patch,long-acting injectable contraceptive, or double-barrier method (condom orintrauterine device with spermicide).

  9. If on immunomodulatory medication, patients must have started it at least 30 daysfrom screening and should not change their medication dose for the duration of thestudy.

Exclusion

Exclusion Criteria:

  1. Have a diagnosis of clinically definite Multiple Sclerosis according to the 2017McDonald'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 clinicallysignificant laboratory abnormality excluding CIS which, in the opinion of theInvestigator, might preclude participation

  7. Are taking benzodiazepines on a regular basis or are unable to suspend intake ofbenzodiazepines

  8. Have received any investigational product within a time-period equal to fivehalf-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 thescientific integrity of the study

  11. Have implants, such as implanted cardiac pacemakers or defibrillators, insulinpumps, cochlear implants, metallic ocular foreign body, implanted neuralstimulators, aneurysm clips, or other medical implants that have not been deemedsafe 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 medicalhistory for differential diagnosis of clinically isolated syndrome (CIS):erythrocyte sedimentation rate (ESR), antinuclear antibody (ANA), complement (C3,C4) and anticardiolipin IgG - IgM

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Magnetic Resonance Imaging
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
May 15, 2025

Study Description

This is a cross-sectional case-control study on patients with a diagnosis of Clinically Isolated Syndrome (CIS) and a group of age- and gender-matched healthy controls.

In this study all participants will undergo two visits. In the first visit, all participants will sign the informed consent form and perform a detailed neurological examination, with administration of a few questionnaires for assessment of symptoms related to CIS/Multiple Sclerosis. Participants will also donate a sample of blood for safety analysis, analysis of biomarkers related to CIS and the glymphatic system, as well as for storage in a biobank. Participants will donate a sample of urine for urinalysis and pregnancy test in females of childbearing potential.

In the second visit, all participants will visit the Mireille Gillings Neuroimaging Centre of the University of Exeter for an MRI scan, that will last about 60 minutes.

Connect with a study center

  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter,
    United Kingdom

    Active - Recruiting

  • University of Exeter

    Exeter,
    United Kingdom

    Site Not Available

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