Active — Not RecruitingNot Applicable

Glymphatic MRI in Clinically Isolated Syndrome

United Kingdom30 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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

✓. 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).

Exclusion criteria

What they're measuring

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI

Timeframe: Through study completion, an average of 7 days

Trial details

NCT IDNCT06274671

SponsorUniversity of Exeter

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Clinically Isolated Syndrome trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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

✓. 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).

Exclusion criteria

What they're measuring

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI

Timeframe: Through study completion, an average of 7 days

To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI

Timeframe: Through study completion, an average of 7 days