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Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03554941
Enrollment
180
Registered
2018-06-13
Start date
2017-07-20
Completion date
2019-12-31
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Insufficiency

Brief summary

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.

Interventions

noise stimulation

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes

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 * 2\. Patients with difficulty ambulation * 3\. Patients with cognitive function

Design outcomes

Primary

MeasureTime frameDescription
deviation of center of gravityChange from baseline afer 30 secs of stimulationdeviation of center of gravity under each condition
motion analysisChange from baseline afer 30 secs of stimulationstep length

Secondary

MeasureTime frameDescription
EEG(Electroencephalography)Change from baseline after 30 secs of stimulationEEG to measured the change of brain activity
BOLD signal change assessed by functional MRIChange from baseline afer 30 secs of stimulationApply tDCS to stimulate brain and simultaneous fMRI exam,assess the neural activities change through BOLD signal

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026