Status:
WITHDRAWN
Vestibular Implants Tested in Human Subjects
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Ohio State University
University of Geneva, Switzerland
Conditions:
Vestibular Disorder
Vestibular Ataxia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 vestibula...
Detailed Description
Aim1: Optimizing information transfer from the VI to the brain: the investigators will study two approaches - altering the transfer function that relates the head's angular velocity to the electrical ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- pregnant
- not scheduled for cochlear implant/vestibular implant surgery
- unable to walk 50m
- other neurological disorder (other than migraine), otologic disease (other than presbycusis)
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04905472
Start Date
August 1 2019
End Date
January 31 2021
Last Update
July 1 2024
Active Locations (3)
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1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
2
Ohio State University
Columbus, Ohio, United States, 432120000
3
Universite de Geneve Hospital (UNIGE)
Geneva, Switzerland, 1211- CH-0