Investigating gray matter damage in primary progressive multiple sclerosis using advanced MRI
Investigating Cortical Gray Matter Demyelination in Primary Progressive Multiple Sclerosis at 7 Tesla
This study is trying to see how gray matter damage affects people with primary progressive multiple sclerosis by using advanced MRI technology to look for signs of brain injury and its link to physical and mental challenges.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Danish Research Centre for Magnetic Resonance Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT04977622 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of gray matter in primary progressive multiple sclerosis (PPMS) using ultra-high field 7 Tesla magnetic resonance imaging (MRI). It will assess the distribution and characteristics of cortical lesions and their relationship to physical and cognitive impairments in PPMS patients. By enrolling 30 individuals diagnosed with PPMS, the study seeks to identify both visible and invisible features of cortical damage that contribute to disease progression. The findings could lead to the development of biomarkers for monitoring and understanding PPMS.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with primary progressive multiple sclerosis who have an Expanded Disability Status Scale score of 6.5 or lower.
Not a fit: Patients with relapsing forms of multiple sclerosis or those with contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the mechanisms of progression in PPMS, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: While studies using standard MRI techniques have been conducted, the use of 7 Tesla MRI for investigating cortical gray matter in PPMS is a novel approach that has not been widely explored.
Eligibility criteria
Show full inclusion / exclusion criteria
PATIENTS Inclusion Criteria: * Diagnosed with primary progressive multiple sclerosis * Expanded Disability Status Scale of ≤ 6.5 * No clinical relapse within last three months * Have the ability to comply with all requirements of the study protocol, as determined by the investigator Exclusion Criteria: * Pregnancy * Pacemaker or other implanted electronic devices * Claustrophobia * Psychiatric disorder * Administration of acute cortisol * Changes in pharmacological treatment within the last 3 months * Any contraindication to MRI * Persons who do not wish to be informed about abnormal findings as part of the investigations HEALTHY CONTROLS Inclusion Criteria: * Able bodied * Have the ability to comply with all requirements of the study protocol, as determined by the investigator Exclusion Criteria: * Pregnancy * Under medication at the time of the experiment (with the exception of contraceptive drugs) * History of neurologic disease * Pacemaker or other implanted electronic devices * History of cerebral hemorrhage or brain damage * Claustrophobia * Psychiatric disorder * Any contraindication to MRI * Persons who do not wish to be informed about abnormal findings as part of the investigations
Where this trial is running
Hvidovre
- Danish Research Centre for Magnetic Resonance — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Vanessa Wiggermann, PhD — Danish Research Centre for Magnetic Resonance
- Study coordinator: Vanessa Wiggermann, PhD
- Email: vanessaw@drcmr.dk
- Phone: +4538626446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.