Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

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.

Study Overview

• Status: Unknown
• Conditions: Vestibular Insufficiency
• Intervention / Treatment: Device: noise stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • TaipeiVGH
    • Contact: Chung-Lan Kao, PHD; Phone Number: (+886)22875-7293; Email: clkao@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: noise stimulation	Device: noise stimulation; noise stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
deviation of center of gravity	deviation of center of gravity under each condition	Change from baseline afer 30 secs of stimulation
motion analysis	step length	Change from baseline afer 30 secs of stimulation
motion analysis	stride length	Change from baseline afer 30 secs of stimulation
motion analysis	trunk or pelvic rotation degree	Immediately after 30 secs of stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG(Electroencephalography)	EEG to measured the change of brain activity	Change from baseline after 30 secs of stimulation
BOLD signal change assessed by functional MRI	Apply tDCS to stimulate brain and simultaneous fMRI exam，assess the neural activities change through BOLD signal	Change from baseline afer 30 secs of stimulation

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2017
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (ACTUAL): June 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2015-12-004C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No