Ignite Creation Date:
2024-05-06 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03554941
Status:
UNKNOWN
Last Update Posted:
2018-06-18
First Post:
2018-03-12
Brief Title:
Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 activationconnectivity 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 activateddeactivated 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None