The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study is a unique blend of new technologies never used in combination with individuals
      diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in
      brain activity, functional brain activation and diffusion in the brain following 6 months of
      structured weight resistance and balance training. Positive changes would indicate that the
      therapy has ignited brain plasticity and may drive the brain to repair itself. These changes
      to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and slowing
      of neural degeneration. No other trials have been published evaluating brain plasticity
      utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in subjects with MS
      undergoing physical training. DTI has demonstrated the ability to find changes (plasticity)
      that occur in the brain and using the MEG findings to focus the DTI analysis will optimize
      the capacity to detect changes secondary to therapy. This quantification will give a better
      understanding of the repair that goes on in the brain, and may potentially revolutionize the
      field of the central nervous system (CNS) rehabilitation. One of the most innovative aspects
      of this study is the full integration of clinical neurobehavioral metrics and functional
      imaging data in conjunction with a proven MS therapy along with quality of life indicators.
      This approach will allow new links to be illuminated as the trajectories of functional and
      structural brain changes (neuroplasticity) are meshed with clinical improvement indices
      collected visit-by-visit. This study will also compare disease modifying treatments (DMTs)
      and their effect(s) on indices of brain plasticity and cognitive and behavioral assessments.
    

Detailed description: 
      Rationale MEG is a direct measure of ongoing neurophysiological activity and is appropriate
      because of spatiotemporal resolution of measurements and immunity of the technique to
      vascular biases that contaminate functional MRI imaging of MS patients.4 MEG will help to
      illuminate the brain bases of motor deficits that exist relative to healthy controls and show
      how the improvements observed behaviorally are reflected in the brain activity that underlies
      those improvements. Since DTI has demonstrated the ability to find changes (plasticity) that
      occur in the brain in patients, it is very promising that DTI will be able to detect evidence
      of neuroplasticity in our research population.5 Using the MEG findings to sharpen the DTI
      analysis, a very powerful combination, will optimize the ability to detect and understand
      changes.

      Objectives Specific Aim 1 - Determine if there are activation differences (see below) in the
      neural regions serving motor function during basic movements using MEG in a group of MS
      patients, comparing MS affected portions of the brain versus non-affected.

      Specific Aim 2 - Determine the effect of a specific 6 month resistance and balance exercise
      program on activation in sensorimotor brain areas using MEG, and correlate changes in these
      neural indices with those of specific movement and balance.

      Specific Aim 3 - Determine the effect of a specific 6 month resistance and balance exercise
      program on brain diffusivity and fractional anisotropy using DTI and correlate changes in
      these metrics with improvement in strength and balance measures in subjects with MS,
      comparing MS affected portions of the brain versus non-affected areas..

      Specific Aim 4 - Determine whether increased fiber integrity (fractional anisotropy) along
      the corticospinal tract is reflected in MEG activation metrics of the primary motor cortex
      from baseline to 6 months in subjects with MS enrolled in the three-month resistance and
      balance exercise program.
    

Intervention name(s): specifically design 6 month resistance training program; 6 months weight resistance and balance program
Intervention type(s): Other; Behavioral
Intervention description(s): Data will be kept on the number of repetitions and amount of weight per exercise session See intervention description; 3 phases first phase-strength improvement using stationary machines second phase-time is divided between stationary machines, balance, dexterity third phase-free weight movements
Other intervention name(s): 6 months weight resistance session,; 50-minute, biweekly sessions for 6 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: multiple sclerosis; exercise; MEG; DTI; Brain changes