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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Ultra-high-field Brain MRI in Multiple Sclerosis

Study Purpose

The MRI scan is one of the most important tools for diagnosing multiple sclerosis (MS) and for monitoring disease progression and medication effects. Increasingly strong MRI magnets (higher field strength) enable us to see abnormalities in the brain in greater detail. On the other hand, it poses challenges because these higher field strength MRIs are more sensitive to disturbances, for example due to motion, including physiological motion such as breathing and swallowing. In current practice, field strengths of up to 3 Tesla are common. The aim of this study is to compare scanning at field strengths of 3 Tesla in 10 MS patients at two different moments (baseline and 6 months) with scanning at field strengths that are higher, namely 7 and 9.4 Tesla, in order to identify the advantages and disadvantages. With the further development of this technique, the investigators may be able to make a better diagnosis in the future and detect subtle changes in the course of the disease more quickly in order to optimize treatments.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Relapsing remitting MS patients (according to the 2017 McDonald criteria) - Age 18-65 years.
  • - New brain MRI lesion in the past 15 months.

Exclusion Criteria:

  • - Non-compatible implanted material/devices.
- Not being able to lie flat long enough (for the MRI) because of another medical condition

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05718947
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zuyderland Medisch Centrum
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Additional Details

Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system. MRI has a prominent role in diagnosing and monitoring disease and treatment and is most suitable tool to study MS pathology in vivo. In recent years there has been research has been much research on the use of 7 tesla MRI in MS. There is a better signal and contrast allowing for higher resolutions. This may contribute to, among other things, higher sensitivity for detecting MS abnormalities, not only in the white matter but also in the gray matter. Furthermore, there is probably also a better specificity. This is due to the improved visualization of MS specific pathological features such as the presence of a central vein in a lesion and paramagnetic rings. In this pilot study, the investigators study whether going beyond the field strength of 7 Tesla (7T) has additional benefits in characterizing MS lesions and to also map the limitations and challenges of scanning above 7T. More specifically, first, whether scanning above 7T might improve sensitivity to white and gray matter abnormalities in MS. Second, whether MS specific pathology, such as the central veins and the paramagnetic rings, are better visualized at the higher compared to lower field strengths. To this end, the investigators want to scan 10 relapsing-remitting MS patients for clinical field strength (3T) and also ultra-high field strengths (7T and 9.4T) at two time points (baseline and after 6 months). If it can demonstrate through this pilot study that scanning at field strengths above 7T can benefit detection of lesions or certain pathological features, the use of this research tool can help us in future studies to better understand MS.

Arms & Interventions

Arms

: MS scan cohort

10 patients with a known clinical diagnosis of relapsing remitting MS according to the 2017 McDonald criteria between ages of 18-65 years, who had a new lesion on their clinical brain MRI in the prior 15 months. The investigators intend to include patients on low-efficacy medication (interferon β, peginterferon, glatiramer acetate, teriflunomide) as well as patients on high-efficacy medication (natalizumab, ocrelizumab, alemtuzumab, fingolimod) to have a varied and representative study population.

Interventions

Diagnostic Test: - Brain MRI (3T, 7T, 9.4T)

All patients will undergo anatomical brain imaging on a 3T, 7T and 9.4T MRI scanner within the same day at baseline and again 6 months later. An optimized protocol for every separate field strength will be run. Sequences will include at least T1-weighted, T2*-weighted and a T2 SPACE or FLAIR sequence. No intravenous contrast will be used.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zuyderland MC, Geleen, Limburg, Netherlands

Status

Recruiting

Address

Zuyderland MC

Geleen, Limburg, 6162BG

Site Contact

Daniel Kreiter

[email protected]

Nearest Location

Site Contact

Daniel Kreiter

[email protected]


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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