Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT03554941

Collaborator

(none)

180

Enrollment

Location

Arm

29.4

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Insufficiency	Device: noise stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

Actual Study Start Date :

Jul 20, 2017

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: noise stimulation noise stimulation	Device: noise stimulation noise stimulation

Arm

Intervention/Treatment

Experimental: noise stimulation

noise stimulation

Device: noise stimulation

noise stimulation

Outcome Measures

Primary Outcome Measures

deviation of center of gravity [Change from baseline afer 30 secs of stimulation]
deviation of center of gravity under each condition
motion analysis [Change from baseline afer 30 secs of stimulation]
step length
motion analysis [Change from baseline afer 30 secs of stimulation]
stride length
motion analysis [Immediately after 30 secs of stimulation]
trunk or pelvic rotation degree

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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
1. Patients with difficulty ambulation
1. Patients with cognitive function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TaipeiVGH	Taipei		Taiwan	11217

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

vghtpe user, Kao Chung-Lan, Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT03554941

Other Study ID Numbers:

2015-12-004C

First Posted:

Jun 13, 2018

Last Update Posted:

Jun 18, 2018

Last Verified:

Jun 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 18, 2018