Gaze and Postural Stability in People With MS: Characterizing Deficits and Response to Treatment

CompletedNot a drug-phase studyMS (type not specified)NCT03521557

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Gaze and Postural Stability

Given to everyone in the trial

  • Standard Care Control

What it measured

Main measures

  • Dizziness Handicap Inventory

    At intervention completion (6 weeks)

Other measures (12)

  • Dizziness Handicap Inventory Follow-up

    1-month follow-up post intervention (10 weeks)

  • Activity Specific Balance Confidence Scale

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

    Walking and mobility
  • Functional Gait Assessment

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

    Walking and mobility
  • Mini-BEST test

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

    Walking and mobility
  • Dynamic Visual Acuity

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

    Vision
  • Passive Angular Vestibulo-ocular Reflex Gain

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

    Nerve conduction testsHow the body handles the medicine
  • Compensatory Saccade Frequency

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

    Nerve conduction tests
  • Compensatory Saccade Latency

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

    Myelin repairNerve conduction tests
  • Gaze Position Error

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

  • Margin of stability

    At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

Who could take part

MS (type not specified) · 20 to 75

Show the full criteria

Inclusion criteria

* Neurologist-diagnosed, clinically definite MS * Expanded Disability Severity Scale (EDSS) score of less than 6.0 * Current complaints of dizziness (DHI > 0) * At risk of falls (determined by > 2 falls in past year or Dynamic Gait Index \<19 or Activity Specific Balance Confidence Scale \<80 * Ability to tolerate repetitive 5 min bouts of angular head motions.

Exclusion criteria

* Central or Peripheral Nervous System disorders (other than MS) * Otologic, Cervical spine, or lower extremity injury in last 12 months * Exercise or alcohol use in last 48 hours * Currently taking vestibular suppressant medications * Peripheral Vestibular Pathology (BPPV, hypofunction, Meniere's disease * Internuclear Opthalmoplegia * MS exacerbation within last 8 weeks * Orthopedic, neurologic, or cognitive comorbidities that would limit participation in the study procedures

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

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      May 2018

    2. Main results due

      Jun 2020

    3. Finished

      Sept 2020

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