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Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

T

Taipei Veterans General Hospital

Status

Unknown

Conditions

Vestibular Insufficiency

Treatments

Device: noise stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03554941
2015-12-004C

Details and patient eligibility

About

Background: Patients with bilateral vestibular hypofunction (BVH) frequently presented with dysequilibrium, dizziness and oscillopsia, leading to increased risk for fall. The mainstream for treatment of vestibular hypofunction remains to be vestibular rehabilitation, yet the effects can be limited in certain cases. Through the application of minimal amount of electrical stimulation, galvanic stimulation can induce polarization in the vestibular nerve, stimulating the saccule, utricle and semicircular canals within the vestibular apparatus. Galvanic stimulation has also been proven to activate cerebral cortex regions such as parieto-insular vestibular cortex (PIVC) and temporal-parietal junction area. It has been documented that vestibular stimulation with stochastic resonance could improve quiet stance stability in patients with vestibular hypofunction. The 3 dimensional effects of dynamic walking as well as the change of vestibular ocular reflex during stochastic resonance vestibular stimulation have never been discussed. Purposes: This 3-year project aims to investigate the effects of vestibular stimulation in VOR, static and dynamic stability, activation/connectivity of cerebral cortex and mechanisms of neuronal changes. Methods: First year the motion analysis and ICS head impulse video goggles were used to observe walking stability and eye movements in 30 healthy and 30 patients with BVH. In the second year, stochastic resonance vestibular stimulation will be applied to 30 healthy and 30 BVH individuals respectively. Using functional MRI, the changes of activated/deactivated areas in the cerebral cortex during stochastic resonance vestibular stimulation will be observed in both groups. In the third year, 60 BVH patients will be randomized into either sham or real vestibular stimulation group. Both groups will receive 3 times per week for 4 weeks of vestibular rehabilitation with exactly the same exercise protocols. SIRT1 related anti-aging genes will be analyzed through blood samples. Expected achievements: Combining safe stochastic resonance vestibular stimulation and exercises in this 3-year project, the neuroprotective mechanisms of vestibular exercises will be elucidated. The optimal strategy for vestibular rehabilitation can thus be established.

Enrollment

180 estimated patients

Sex

All

Ages

22 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • vestibular insufficiency

Exclusion criteria

    1. chronic diseases that may compromise vestibular function(eg. benign paroxysmal positional vertigo, post-traumatic vertigo, degenerative neural diseases, Whiplash injury), and patients with intracranial metal inplants or history of seizure
    1. Patients with difficulty ambulation
    1. Patients with cognitive function

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

180 participants in 1 patient group

noise stimulation
Experimental group
Description:
noise stimulation
Treatment:
Device: noise stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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