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Worksheet Summary for Vestibular/Balance

(1) Based on data and experience, develop list of otologic conditions to be targeted in the next 5 to 10 years. Include rationale.
Disease/Disorder/
Condition/ Target
PH Significancee.g., high prevalence, severe dz, limited tx options Treatment Optionse.g., none, ineffective, low benefit/risk ratio Disease Severitye.g., dire consequences, dire disabilities, compromised QOL Evidence Base e.g., none, some, limited Stage of readiness for research involving humans
Meniere's disease Very high

Unknown efficacy;
many treatments are used but comparisons with one another and comparisons to natural history of disease are very slim

Very debilitating in many people, compromised QOL. Very limited

Areas that are ready immediately:
Epidemiology
   Registry
    Stringent criteria
    Databank
   Genome-based association studies
Diagnostic studies
    Imaging – MRI
    VEMP
    ECOG
    DPOEs

Age-related vestibular dysfunction

Likely to be very high; contribution to falls in the elderly which have enormous mortality and economic impact

Physical therapy,

possible Vestibular Implant

Likely to be very high

Very limited; some studies that do demonstrate loss of hair cells and Scarpa’s ganglion cells with age; also studies that show decline in VOR with age

Areas that are ready immediately:
Epidemiology
   Determination of peripheral
    vs. central etiology
    Genome-based association studies

Analysis of RFs for falls
Migraine and vestibular dysfunction Very high

Unknown and/or

limited efficacy

Can be very severe

and debilitating
Very limited; genetics of some forms of migraine are known but relationship to vestibular symptoms is unknown

Areas that are ready immediately:
Epidemiology
    Peripheral and/or central origin

Genome-based association studies
Incomplete compensation for vestibular hypofunction Very high

Unknown and/or
limited efficacy
Role for PT
Vestibular implant

Can be very severe

Very limited;
Role of co-morbidity

remains to be determined

Areas that are ready immediately:
Studies of vestibular dysfunction and balance associated with:
    Radiation for AN
    IT gentamicin
    Labyrinthectomy
    AN surgery

Trauma
Superior semicircular canal dehiscence Prevalence is currently unknown; has relevance to understanding other disorders of the ear Surgical repair; indications are being determined and outcomes monitored Can be very disabling

Physiological evidence of effects of dehiscence on vestibular function is strong; Underling cause is unknown

Areas that are ready immediately:
Diagnostic testing

Genome-based association studies
Autoimmune inner ear disease – vestibular  dysfunction Prevalence relatively low but impact on understanding other disorders of the ear is high Efficacy of steroids has been established; other treatments still in investigational status Can be very disabling Evidence exists for autoimmune etiology; underlying cause is unknown

Areas that are ready immediately:
Diagnostic testing

Genome-based association studies

(2) For each target otologic condition, categorize the current state of knowledge regarding the condition and its interventions(if any) and the stage of research necessary for full development of the intervention.

Disease/Disorder/
Condition/ Target
Understanding of Dz/Disorder/ Condition e.g., natural hx, treatment altering natural course Understanding of patho-physiology Is there a therapeutic target Describe intervention: any modality e.g., surgery, drug, device, drug, behavior Stage of development of intervention e.g., basic understanding/early translation, preclinical, clinical, definitive clinical trials, late translation
Meniere’s disease Incomplete – natural history is variable and needs to be more carefully studied

Incomplete – approach that involves identification of candidate genes and studies of vestibular effects of knockouts of these genes in mice may be useful

Not clear at present time Staged approach to treatment:
  • low salt, life style
  • diuretic
  • steroids, gentamicin
  • Basic understanding
    May be the time for analyses of staged approaches to treatment
    Animal model representative of pathophysiology is needed

    Improved diagnostic tests

    Age-related vestibular dysfunction

    Incomplete – interactions of peripheral and central disorders is inadequate

    Incomplete – need to integrate approaches to studies of balance function

    Yes. e.g., Loss of vestibular function due to hair cell and ganglion cell death

    Regeneration medicine
    Vestibular implant

    Basic understanding
    Animal models

    Improved diagnostic tests Analysis of RFs for falls
    Migraine and vestibular dysfunction Incomplete

    Very incomplete

    Not at present

     

    Basic understanding
    Epidemiology

    Gene association studies
    Incomplete compensation for vestibular hypofunction

    Different disorders result in vestibular hypofunction

    Incomplete

    Not at present

    Regeneration

    Vestibular implant

    Basic understanding of
    vestibular compensation

    Superior semicircular canal dehiscence Effects of dehiscence on vestibular function have been described Cause of dehiscence and thinning is incomplete Not at present

     

    Diagnostic testing

    Gene association studies
    Autoimmune inner ear disease – vestibular  dysfunction Natural history has been described for hearing loss; effects on vestibular function are unclear Pathophysiology is not understood at level of immunologic dysfunction or hair cell/afferent disorder Not at present

    Regeneration

    Vestibular implant

    Diagnostic testing

    Gene association studies

     

    Common Themes:

    1. Need to improve vestibular diagnostic tests:

        – VEMPs
        – Imaging (MRI – utility in Meniere’s, vestibular neuritis)
        – Evaluation of VOR in response to rapid head movements
        – Evaluation of otolith function
        Utility of these tests in longitudinal studies

    2. Need better understanding of epidemiology across all vestibular pathologies.
    3. Need for gene association studies for many vestibular pathologies.
    4. Need for validated outcome measures in dizziness and balance disorders. Something analogous to Stage 1 behavioral study. It would be appropriate for these validated outcome measures to be developed before large-scale clinical trials.

    Possible consideration:

    Establish a Meniere’s disease ‘registry’ which involves multiple centers with agreed upon criteria for assessment of symptoms, stage of the disease, vestibular function, auditory function, and follow-up. Gene association studies to be performed on patients who enter the study. This registry and the centers involved will enable us to study the natural history of Meniere’s disease. We recommend beginning with a group of established centers with recognized expertise in Meniere’s disease. As a part of the development of this registry, standardized criteria will be developed by investigator’s participating in the registry for diagnosis, evaluation, and follow-up. This registry will then serve as the basis for future therapeutic intervention trials. This registry could, in the future, be opened for enrollment of patients by any practitioner who treats patients with Meniere’s disease.