Status unknownProgressive MSNCT04977622

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What it measured

Main measures

  • Distribution of cortical lesions in PPMS

    Baseline

    MRI lesions
  • Volume of cortical lesions in PPMS

    Baseline

    MRI lesionsThinking and memory
  • Identify central veins and the presence of paramagnetic rims for cortical lesions

    Baseline

    Disability progressionMRI lesionsSmouldering inflammationThinking and memory
  • Quantitative assessment of myelin density in cortical lesions, perilesional gray and white matter, and normal appearing cortex using myelin water imaging

    Baseline

    MRI lesionsMyelin repair
  • Quantitative assessment of magnetization transfer in cortical lesions, perilesional gray and white matter, and normal appearing cortex

    Baseline

    MRI lesionsMyelin repair
  • Quantitative assessment of fractional anisotropy in cortical lesions, perilesional gray and white matter, and normal appearing cortex using diffusion tensor imaging data

    Baseline

    MRI lesions

Other measures (7)

  • Number of cortical lesions in the primary sensorimotor cortex (SM1)

    Baseline

    MRI lesions
  • Cortical lesion volume in the primary sensorimotor cortex (SM1)

    Baseline

    MRI lesions
  • Motor function

    Baseline

    Disability progressionWalking and mobility
  • Sensory acuity

    Baseline

    Disability progression
  • Regional metabolite concentration of the SM1

    Baseline

    MRI lesions
  • Functional MRI data for the assessment of temporal synchronization

    Baseline

    Disability progressionMRI lesionsNerve conduction tests
  • Cognitive performance and relationship to MRI measures (Exploratory)

    Baseline

    MRI lesionsThinking and memory

Who could take part

Progressive MS · 18 to 80

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Progressive-onset multiple sclerosis (PPMS) occurs in about 15% of all people living with MS. PPMS remains understudied, and most disease-modifying treatments are ineffective for PPMS. To date, it is unknown why some people progress immediately from MS onset. The present study will assess the role of gray matter in PPMS by characterizing it with ultra-high field magnetic resonance imaging (MRI). While both white and gray matter are affected in relapsing MS, in PPMS tissue damage is primarily in the cortex. Cortical gray matter consists largely of neuronal cell bodies, which send electrical signals to create a functional response, such as arm or leg movement. While white matter damage slows the signal response, cortical damage inhibits the initial creation of electrical signals. There is a great need to research and develop scientific biomarkers to identify and monitor progression and repair in PPMS. In this project, 7 Tesla MRI is used to investigate the cortical gray matter in people with PPMS. 7 Tesla MRI is the safest and most detailed way to study the brain. Because the cortex is only a few millimeters thick, it has been traditionally difficult to investigate. At 7 Tesla, different layers and lesions within the cortex can be seen. In addition, this project will use myelin-sensitive MRI to determine the biological underpinnings of both cortical lesions and the 'normal appearing' cortical damage in PPMS. This will answer relevant questions about the brain's capacity for repair, the extent of demyelination and the occurrence of inherent cortical remyelination and provides an avenue for the development of novel clinical MR biomarkers tailored to PPMS.

Papers

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History

    1. Started

      Nov 2021

    2. Main results due

      Jun 2024

    3. Finished

      Dec 2024

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