The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and programming software. The implant is designed to preserve hearing in the implanted ear. The vestibular implant is surgically placed under the skin just behind the ear in the mastoid bone and has an electrode that stimulates the vestibular nerve. A sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with bilateral vestibulopathy (BVP) who have normal to severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of their balance and hearing and self-reported questionnaires on their balance and general health.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
vestibular implant
ZAS Augustinus
Antwerp, Wilrijk, Belgium
RECRUITINGC.H.U. Insular & Materno-Infantil Hospital.(SCS) Las Palmas University. (ULPGC)
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
RECRUITINGClinica Universitad de Navarra (CUN)
Pamplona, Navarre, Spain
RECRUITINGChange in Dynamic Gait Index (DGI) score from baseline to six months post-activation of the vestibular implant
Change in Dynamic Gait Index (DGI) score. Score range (0-24). Higher score means better outcome.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Functional Gait Assessment (FGA) score from baseline to six months post-activation of the vestibular implant
Change in Functional Gait Assessment (FGA) score. Score range (0-30). Higher score means better outcome.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Posturography - Sensory Test score from baseline to six months post-activation of the vestibular implant
Change in Posturography - Sensory Organization Test score. Score range (0-100%). Higher score means better outcome.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Posturography - Limits of Stability test score from baseline to six months post-activation of the vestibular implant
Change in Posturography - Limits of Stability test score. Scale range (0-100). Higher score means better outcome.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Dizziness Handicap Inventory (DHI) score from baseline to six months post-activation of the vestibular implant
Change in Dizziness Handicap Inventory (DHI) score. Score range (0-100). Higher score means worse outcome.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Fall Efficacy Scales International (FES-I) score from baseline to six months post-activation of the vestibular implant
Change in Fall Efficacy Scales International (FES-I) score. Score range (16-64). Higher score means worse outcome.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Device or procedure related adverse events in participants up to six months post-activation of the vestibular implant.
Listing of device or procedure related adverse events.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in hearing thresholds up to six months post-activation of the vestibular implant
Pre- vs post-surgery hearing thresholds difference (dB HL) measured at 250, 500, 1000, 2000, 4000, and 8000 Hz.
Time frame: Baseline (pre-surgery) to 6 months post implant surgery
Change in EuroQol 5D (EQ5D-5L) quality of life score from baseline to six months post-activation of the vestibular implant
Change in EuroQol 5D (EQ5D-5L) quality of life score. Score range (-0.594-1). Higher score means better outcome.
Time frame: Baseline (pre-surgery) to 6 months post implantation
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