10 Clinical Trials for Various Conditions
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.
Other Disorders of Vestibular Function, Bilateral, Bilateral Vestibular Deficiency (BVD), Gentamicin Ototoxicity, Labyrinth Diseases, Vestibular Diseases, Sensation Disorders, Bilateral Vestibular Hypofunction, Bilateral Vestibulopathy, Aminoglycoside Ototoxicity
The purposes of this research are to 1) utilize virtual reality (VR) to evaluate the exercise dose required to improve symptoms in those with vestibular (dizziness) disorders, 2) compare VR vestibular exercises to standard exercises, and 3) compare exercise performance outcomes to healthy controls without vestibular disorders. Even though more than 35% of those over 40, and \~50% of those who have had concussion have such symptoms, the dose of specific exercises targeted to improve symptoms is not well defined. In this study, the investigators will use a wireless VR device to measure key parameters and response to exercise. Another advantage of the VR device is the ability to control what the individual can see while performing the exercise. In normal daily life, moving objects and distracting backgrounds can make vestibular exercise too uncomfortable to perform. Using these methods, the investigators aim to determine the appropriate type and amount of exercise required for symptom improvement. This study will also compare the effectiveness of performing exercises in the virtual reality environment to standard physical therapy and to healthy persons without history of vestibular disorders. Three categories of vestibular disorders will be investigated with an instrumented and usual therapy group of 1) Unilateral hypofunction, 2) bilateral hypofunction, and 3) post-concussion.
Vestibular Disorder
The purpose of this study is to determine whether the BrainPort™ balance device is safe and effective in the treatment of balance disorders in patients with Bilateral Vestibular Dysfunction.
Vestibular Disease
Bilateral vestibular hypofunction affects more than 64,000 adults in the US and leads to a substantial decline in quality of life. Bilateral vestibular hypofunction (BVH) is a condition characterized by a bilateral impairment of vestibular sensory function2. BVH often occurs without a known cause but can result from a viral infection, exposure to ototoxic drugs, vestibulo-cochlear nerve tumors, Meningitis, or Meniere's disease2. The results of a nationally representative survey estimate that between 64,000 and 193,000 adults in the US (28 to 85 per 100,000) are affected2. However, due to a lack of standardized vestibular screenings in older adult populations, the true prevalence of BVH is likely underestimated. Aging is also capable of producing a bilateral reduction in vestibular function, yielding a sub-type of BVH labeled as "Presbyvestibulopathy". In fact, more than 50% of adults over the age of 65 show evidence of vestibular impairment3 and recent data suggest that age-related vestibular declines may begin as early as age 403. The symptoms of BVH - oscillopsia (bouncing vision whilst the head is moved), imbalance, gait instability, and dizziness - manifest secondary to an insensitivity of the vestibular system to self-motion cues (i.e., rotation, translation, or tilting of the head). Relative to unilateral vestibular lesions, the symptoms of BVH lead to greater perceived disability and a worsened health-related quality of life4; the economic burden of BVH has been estimated to be $13,019 per patient, nearly 4-times the burden of unilateral vestibular disease4. Adding to the economic and health-related burden is the substantial increase in fall risk; Ward, et al. (2015) showed that patients with BVH display an age-adjusted fall risk that is 9.9x higher than patients without a diagnosis of BVH but who report imbalance/dizziness, and 31x higher than the asymptomatic general population2; Sun, et al. (2015) reported that patients with BVH experience an average of 19 falls per year and Herdman and colleagues showed that over half of patients with BVH aged 65-74 reported a history of falls5. Given the substantial burden of BVH, the identification of new approaches for improving the functional status of these individuals is critically important. To meet this need, we propose to investigate the use of subthreshold vestibular stimulation as a novel strategy for improving vestibular function in patients with bilateral vestibular dysfunction. The nervous system responds to changes in external or internal conditions by altering the behavior of neurons through multiple forms of neural plasticity. A specific form of plasticity, "homeostatic plasticity", stabilizes neural activity by driving the excitability of neurons toward a "set-point" level of activity6. Over the last six years, new data have come to light showing that the vestibular system also possess a robust capacity to modulate sensitivity to self-motion cues in response to prolonged periods of motion. Dietrich and Straka showed direct evidence of a bidirectional modulation of neuronal firing rates in the oculomotor neurons of Xenopus laevis (i.e., via the lateral canal driven aVOR) following subthreshold and suprathreshold yaw rotations7. In a sample of healthy adults, Fitzpatrick and Watson (2015) showed a 248% decrease in perceptual sensitivity and a 50% decrease in the sensitivity of the descending vestibular pathways (elicited by galvanic vestibular stimulation) following a single ten-minute period of large amplitude (suprathreshold) rotations8. Recently, Keywan and colleagues found that the sensitivity to interaural (IA) translation cues was increased 28.8% immediately following a 20-minute block of low-amplitude (subthreshold) translations9; a follow up study using the same subthreshold IA translation stimulus yielded an average improvement in sensitivity (i.e., reduction in self-motion perceptual thresholds) of 39%10. Collectively, these results demonstrate a capacity to use motion perturbations (i.e., low, or high levels of vestibular stimulation) to dynamically adjust the sensitivity of the vestibular system on both the single neuron and behavioral levels. The ability to use subthreshold motion stimuli to drive plasticity in the vestibular system motivates this study. We aim to determine if the delivery of a subthreshold motion stimulus before balance training leads to greater improvements in postural control for individuals with bilateral vestibular hypofunction.
Vestibular Hypofunction, Bilateral Vestibular Hypofunction, Presbyvestibulopathy
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.
Bilateral Vestibular Hypofunction, Bilateral Vestibular Deficiency, Bilateral Vestibulopathy, Gentamicin Ototoxicity, Aminoglycoside Toxicity, Vestibular Diseases, Sensation Disorders, Labyrinth Diseases, Other Disorders of Vestibular Function
The purpose of this study is twofold: 1) Develop norms for measures of inner ear function and psychological health, and 2) Examine the feasibility of using the MINDGAPS system (a remote monitoring system) to track progress during physical therapy or rehabilitation for inner ear problems following a concussion or mild Traumatic Brain Injury.
Vestibular Hypofunction
The proposed research is relevant to vestibular science and the general public because age-related vestibular hypofunction is a major contributor to poor balance, falls, and other adverse health outcomes. In this investigation the investigators will: 1) assess the preliminary efficacy of a novel intervention system for improving vestibular function and dizziness in community-dwelling older adults, 2) assess the safety and feasibility of the this system, and 3) assess the acceptability and implementation potential of this system, prior to a large-scale, R01-level investigation.
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 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.
Other Disorders of Vestibular Function, Bilateral, Bilateral Vestibular Deficiency (BVD), Gentamicin Ototoxicity, Labyrinth Diseases, Vestibular Diseases, Sensation Disorders, Bilateral Vestibular Hypofunction, Bilateral Vestibulopathy, Presbyvestibulopathy, Aminoglycoside Ototoxicity
The human body uses vestibular feedback in coordination with visual and somatosensory information to maintain balance and posture. However, various inner-ear disorders due to aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular feedback, which makes it difficult for an individual to maintain balance. This study investigates the use of a hidden and noninvasive balance device EquiCue™ V1 developed by Innervo Technology for vestibular substitution. EquiCue™ V1 is a retainer-like intraoral electronic balance aid entirely worn inside the oral cavity and provides in-situ sensory feedback of head tilting and motion on the roof of the mouth. The feedback is delivered by applying small and controlled electrical pulses at precise locations on the palatal surface according to an encoded pattern. This pilot study is to determine how this alternative sensory feedback on the roof of the mouth can be used to improve balance for patients with vestibular loss.
Vestibular Disorder
The purpose of this study is to determine whether exercises relieve the symptoms of dizziness and imbalance in people with vestibular deficits and improves the ability to see clearly during head movements. We hypothesize that the performance of specific adaptation and substitution exercises will result in an improvement in visual acuity during head movements while those patients performing placebo exercises will show no improvement.
Vestibular Neuronitis, Vestibular Neuronitis, Bilateral, Vestibular Schwannoma