Clinical Research Directory

Multichannel Vestibular Implant Early Feasibility Study

Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of vestibular hair cell function. Preclinical studies have demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular prosthesis can partially restore vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other causes of inner ear dysfunction.

Long Term Outcomes After Vestibular Implantation

Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.

Differentiation of Human Body Balance Disorders

Our research aims to analyze the possibilities of functional assessment of imbalances in the human body. Using the available, commonly known and used tests and devices for objective examination of static and dynamic body balance, as well as changes in the tension of selected muscles of the cervical spine in static and dynamic conditions, depending on visual control or its absence, we hope to identify important research tools that help to differentiate the causes of imbalances. Studies conducted on a group of healthy people and groups of patients: after a stroke, with changes in the posterior cords of the spinal cord, with labyrinth disorders, with degenerative changes in the spine, with visual impairments, and in healthy people, seem to be important in the analysis of the discussed topic. The investigators will answer the following detailed research questions: 1. Does the type of disease/disease or its absence affect the human balance in the Romberg test? 2. Do visual defects affect the tension of the muscles of the cervical spine? 3. Do changes in the muscle tension of the cervical spine affect the ability to maintain balance in the Unterberger test? 4. Do the mobility deficits in the cervical spine coincide with cervical or labyrinthine balance disorders in the differential test for vertigo and in the Fukuda test? 5. How does the tension of the muscles of the cervical spine change in the tested groups on the stable and unstable, depending on the vision control? 6. Does the type of disease/illness or its absence affect changes in the tension of the muscles of the cervical spine, and does it correlate with the balance of the body on a stable and unstable surface? The results of the research may facilitate the functional differentiation of imbalances in the human body. The investigators hypothesize that functional tests will help determine the cause of imbalance in the human body. This will allow us to determine with high probability the dominant cause of balance disorders (eye disorders, changes in the cervical spine / musculoskeletal system, labyrinth, proprioceptors, cerebellum, posterior cords of the spinal cord), already at the initial stage of diagnosis. The research will improve the process of implementing effective treatment and therapeutic procedures.

Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.

Vestibular Implantation in Older Adults

Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to fifteen older adults (age 65-90 years at time of enrollment) with ototoxic or non-ototoxic bilateral vestibular hypofunction.