Gaze and Postural Stability in Multiple Sclerosis
Condition: Multiple Sclerosis; Vertigo; Dizziness; Falls Injury
MeSH terms: Vertigo; Multiple Sclerosis; Sclerosis; Dizziness
Study type: Interventional

Summary: 
      In order to provide information that will improve therapy, the goals of this project are to
      determine if persons with MS with complaints of dizziness and at risk for falls can improve
      their balance and vision stability as a result of a bout of specific treatment. This project
      seeks to do this by conducting an experiment where people with MS are randomly assigned to a
      group that practices activities known to help improve inner ear function or a group that
      practices activities known to improve endurance and strength but that should not change inner
      ear function. Such a comparison will allow us to gain understanding of how the inner ear
      system is affected in MS and how it responds to treatment.
    

Detailed description: 
      A variety of sources of evidence suggest altered vestibular function in people diagnosed with
      MS (PwMS). These sources of evidence include [a] subjective complaints of dizziness /
      vertigo, [b] altered subjective visual vertical, [c] altered vestibular evoked myogenic
      potentials, [d] altered performance on the vestibular dominant components of the sensory
      organization test, and [e] pilot reports of gaze stabilization deficits during vestibular
      ocular reflex (VOR) testing from the investigator's research group. These findings suggest
      vestibular deficits are present in PwMS. Epidemiological studies document cerebellar and
      brainstem involvement in 23% of PwMS at disease onset, increasing to 82% after longstanding
      illness. These vestibular deficits contribute to motion sensitivity, dizziness, imbalance,
      and falls. Regardless, dizziness and falls have a significant negative impact on quality of
      life. Multiple studies show that falls are a major disabling symptom in MS affecting
      approximately 75% of PwMS. The high incidence of falls in MS, is an important health concern
      due to its associations with injury-related morbidities, mortality and financial costs.

      The vestibular pathways responsible for gaze and postural stability, as well as sensory
      integration reside in the brainstem, cerebellum and spinal cord. Demyelination of the
      pathways involving the vestibular nuclei complex within the brainstem and cerebellum
      adversely affect angular vestibulo-ocular reflex,vestibulo-spinal reflex function and sensory
      integration in PwMS. While evidence reports impairments in posturography and otolith mediated
      responses (vestibular evoked myogenic potentials), the responses mediated by the semicircular
      canal end organs and vestibular pathways have not been examined. Specifically, the learning
      and retention of gaze and postural stability as a result of task specific training program
      has not been studied in a well controlled clinical trial.

      This proposal seeks to examine gaze and postural stability outcomes utilizing outcome
      measures that span the World Health Organization's International Classification of Function,
      Disability, and Health. Following completion of the baseline examination, PwMS will be
      randomized to one of two interventions: An Experimental Gaze and Postural Stability Training
      Group (GPS) or a Standard Care Aerobic Exercise Control Group (SCA). The two groups differ
      only by the presence of the GPS program in the experimental group. Both groups will
      participate in supervised exercise 3 times per week for 6 weeks followed by a post
      intervention testing period . After one month of no training, both groups will be brought
      back for a final follow-up examination to determine the retention of any training induced
      changes.
    

Intervention name(s): Gaze and Postural Stability; Standard Care Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The duration and content of the GPS intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises.; The Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength.
Other intervention name(s): GPS; Standard Care Control (SCC)
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2 group x 3 time interval
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment