Vestibular Implants Tested in Human Subjects
Withdrawn before enrolling · Not applicable
Conditions studied: Vestibular Disorder, Vestibular Ataxia, Vestibular Loss, Bilateral
In brief
The goal of this study is to improve the vestibular implant's ability to reduce the vestibular-dependent perceptual, postural, and visual symptoms that affect patients with severe peripheral vestibular damage. The long-term research plan is focused on exploring the three questions which must be answered to assess the clinical utility of a vestibular implant (VI) in vestibulopathic patients - i) how can information transfer from the VI sensors to the brain be optimized; ii) how does the three-dimensional angular velocity information provided by the VI interact in the brain with other sensorimotor (vision, otolith, efferent) signals; and iii) how effectively does the VI alleviate the behavioral deficits and subjective symptoms experienced by patients with severe vestibular damage. The current study will be used to focus on two key subsets of these questions. Over one year, the investigators will study approximately 5 patients who have severe bilateral vestibular damage and functioning VI's, which will focus on aim 1: how the angular velocity information sensed by the VI can be optimally transferred to the brain; and aim 2: how effectively the VI improves the clinical status of vestibulopathic patients when they receive acute and sub-acute (3 days) motion-modulated stimulation. In sum, the investigators aim to improve the efficacy of the VI in human subjects by developing new knowledge about how the brain processes motion cues provided by the VI and correlating this information with behavioral outcomes.
Key facts
- Study ID
- NCT04905472
- Run by
- Massachusetts Eye and Ear Infirmary
- People needed
- 0
- Starts
- 2019-08-01
- Expected to finish
- 2021-01-31
- Last updated by the study team
- 2024-07-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- scheduled for cochlear implant CI surgery because of deafness
- minimum of five year history of documented absence of auditory \& vestibular function, based on review of their audiograms \& vestibular tests
- Specific vestibular criteria are: peak ice water caloric response of less than 3 deg/s for each ear; yaw VOR time constant < 3.0 sec and gain < 0.25; and reduced head impulse gain (<0.25) for all canal planes.
- Specific audiographic criteria: 80dB or greater sensorineural hearing loss in both ears
You may not qualify if…
- pregnant
- not scheduled for cochlear implant/vestibular implant surgery
- unable to walk 50m
- other neurological disorder (other than migraine), otologic disease (other than presbycusis)
Where it is running
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
- Ohio State University — Columbus, Ohio, United States
- Universite de Geneve Hospital (UNIGE) — Geneva, Switzerland
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.