Magnetic Resonance Imaging to Detect Brain Damage in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study will evaluate the ability of magnetic resonance imaging (MRI) using different
      magnet strengths (1.5, 3 and 7 Tesla) to detect damage in different parts of the brain in
      patients with multiple sclerosis. The higher the Tesla, the greater the ability to see brain
      changes. Healthy subjects will also be studied to compare findings in patients with those of
      normal volunteers.

      Healthy normal volunteers and patients with multiple sclerosis 18-65 years of age may be
      eligible for this study. Patients should have minimal clinical disability. Candidates are
      screened with a medical history, physical examination, and blood and urine tests.

      Participants undergo three MRI examinations. The first is on a 1.5 Tesla machine. The second
      and third - at 3 Tesla and 7 Tesla - are done within 30 days of the first. Each procedure
      takes about 2 hours. Before and after the 7 Tesla examination, subjects have an
      electrocardiogram (EKG), their blood pressure and temperature are measured and a blood sample
      is drawn.

      MRI uses a magnetic field and radio waves to produce images of body tissues and organs. This
      test has several advantages over x-ray methods, such as the ability to see more clearly
      inside the brain and to see chemical changes that might occur in specific neurological
      diseases. Also, since x-rays are not used, there is no radiation risk. Radio waves are
      generated and changes in magnetic fields are measured and analyzed by computer. For the
      procedure, the subject lies on a table that is moved into a metal cylinder (the MRI scanner)
      that has a strong magnetic field. Earplugs are worn to muffle loud thumping noises caused by
      the electrical switching of the radio frequency circuits. During the MRI, subjects receive an
      injection of a contrast agent called Gadolinium, which brightens the images.

      ...
    

Detailed description: 
      OBJECTIVE: Among the factors contributing to the poor identification of grey and white matter
      pathology of multiple sclerosis (MS) patients, the low signal-to-noise ratio and
      consequential poor resolution of magnetic resonance imaging (MRI) obtained at conventional
      magnetic fields (i.e. 1.5 Tesla) play a significant role. Preliminary results suggest that
      7T-MRI has the capability to disclose characteristics of chronic white matter lesions'
      heterogeneity in MS, not seen at lower field MRI. We now aim to extend those results by
      investigating whether lesions' heterogeneous appearance pertain not only to chronic lesions,
      i.e. those studied thus far, but also to newly formed lesions, i.e. those enhancing upon
      gadolinium injection. The latter can be identified only by imaging at 7T with contrast
      injection those MS patients known to already have active lesions.

      STUDY POPULATION: Up to 145 patients (age range: 18-65, range in the Expanded Disability
      Status Scale: 0-4.5) with definite MS according to Poser criteria or other diseases of the
      central nervous system resembling MS from an imaging stand point and up to 120
      age/gender-matched healthy volunteers will be enrolled.

      DESIGN: Patients previously shown to meet both the clinical and MRI criteria for MS and an
      equivalent number of gender- and age-matched healthy volunteers will be studied. Initially,
      both patients and healthy individuals will have conventional 1.5Tesla MRI T1-weighted scans
      without contrast, whereas patients will also have post-contrast scans. Next, both groups of
      subjects will be imaged on both the 3 Tesla and 7 Tesla MRIs in a random order. In each 3
      Tesla and 7 Tesla MRI study the examination will include the following sequences: 3
      dimensional inversion-recovery-prepared fast spoiled gradient recalled images,
      3D-fluid-attenuated inversion recovery and double inversion recovery in addition to T1 and T2
      conventional weighted images.

      A second group of 15 patients with or without clinical relapse who are known to be in an
      active stage of MS as seen by post-contrast MRI will be imaged. Each patient may undergo a
      standard 3T MRI within the two weeks before the 7T MRI (if needed, as no information
      regarding his/her disease status are otherwise available from 3T MRI performed under other
      NIB protocols). The former will allow ascertaining in advance his/her status of lesions
      activity, thus providing an adequate number of patients with active lesions imaged at 7T.
      Each patient may need to repeat his/her scan three times in case of magnetic instability
      during image acquisition. Additional 3T and 7T MRIs will be performed after 1 and 6 months to
      follow active lesions evolution over time.

      A third group of patients with MS or any other disease of the central nervous system
      manifesting in magnetic resonance imaging with lesions of the white matter and grey matter
      which could mimic MS will be included. Each patient will undergo a 3T MRI inclusive of
      post-contrast sequences as well as a 7T MRI.

      OUTCOME MEASURES: The number of cortical lesions as well as white matter and deep grey
      abnormalities will be computed on images obtained at 1.5, 3 and 7 Tesla MRIs. The study will
      not aim at conducting a formal comparison of cortical or white matters lesions seen on 3
      Tesla and 7 Tesla. Instead, the goal is to provide preliminary information that can be used
      to design a formal analysis of the sensitivities of the two platforms in studying those
      abnormalities seen in MS. Active lesions found to be conspicuous upon contrast injection will
      be compared between T1 and gradient echo images at 7T. Additionally, the evolution of active
      lesions over time at 7T will be evaluated.
    

Keywords: Multiple Sclerosis; Magnetic Resonance; MRI; Magnetic Field; MS