CClinicalTrials.gg
Status unknownNCT03554941Updated Jun 18, 2018

Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

An interventional study of noise stimulation in Vestibular Insufficiency, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 22 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-18.

Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
22 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vestibular Insufficiency
03

In context

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • vestibular insufficiency

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    noise stimulation

    noise stimulation

    Device: noise stimulation

Interventions

  • Devicenoise stimulation

    noise stimulation

06

What researchers measure

Primary outcomes

  1. deviation of center of gravity

    deviation of center of gravity under each condition

    Time frame: Change from baseline afer 30 secs of stimulation

  2. motion analysis

    step length

    Time frame: Change from baseline afer 30 secs of stimulation

  3. motion analysis

    stride length

    Time frame: Change from baseline afer 30 secs of stimulation

  4. motion analysis

    trunk or pelvic rotation degree

    Time frame: Immediately after 30 secs of stimulation

Secondary outcomes

  1. EEG(Electroencephalography)

    EEG to measured the change of brain activity

    Time frame: Change from baseline after 30 secs of stimulation

  2. BOLD signal change assessed by functional MRI

    Apply tDCS to stimulate brain and simultaneous fMRI exam,assess the neural activities change through BOLD signal

    Time frame: Change from baseline afer 30 secs of stimulation

07

Study locations

1 of 1 sites recruiting
  • TaipeiVGH
    Taipei, 11217, Taiwan
    Recruiting
08

References and documents

Publications

  • Chen PY, Jheng YC, Wang CC, Huang SE, Yang TH, Hsu PC, Kuo CH, Lin YY, Lai WY, Kao CL. Effect of noisy galvanic vestibular stimulation on dynamic posture sway under visual deprivation in patients with bilateral vestibular hypofunction. Sci Rep. 2021 Feb 19;11(1):4229. doi: 10.1038/s41598-021-83206-z. PubMed 33608568 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03554941
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
vghtpe user (Kao Chung-Lan, Taipei Veterans General Hospital, Taiwan) — Principal investigator
First posted
Jun 13, 2018
Start date
Jul 20, 2017
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Jun 18, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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