Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500975
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Long Term Outcomes After Vestibular Implantation
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Long Term Outcomes After Vestibular Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
There is no widely available adequately effective treatment for individuals suffering chronic imbalance postural instability and unsteady vision due to loss of semicircular canal function despite vestibular rehabilitation exercises The experience of 15 adults with bilateral vestibular hypofunction who underwent unilateral surgical placement of a vestibular implant and have received continuously motion-modulated electrical stimulation of the vestibular nerve for 6 months revealed vestibular implantation VI and motion-modulated stimulation can partially restore vestibular sensation and reflexes that normally maintain steady posture and vision This study will examine long-term outcomes after vestibular implantation Within constraints on power andor minimum detectable effect size due to limits on the number of study participants permitted under IDE G150198 the study will test the following hypotheses regarding unilateral vestibular implantation activation and long-term 3 years continuousdaily use
1 It is safe as determined by incidence of serious unanticipated adverse device-related events and as further quantified by proportions of
1 implanted ears with preservation of 4-frequency pure tone average for 05124 kHz air-conducted audiometric detection thresholds 50 decibel dB HL and ear-specific speech discrimination 50 consistent with Class A or B per American Academy of Otolaryngology-Head and Neck Surgery 1995 guidelines 13 or 30 dB change from preoperative baseline if preoperative baseline is 20 dBHL and ear-specific speech discrimination 30 worse than preoperative baseline if preoperative baseline is 80
2 participants with preservation of useful sound-field hearing by the above criteria and
3 implanted ears with preservation of otolith endorgan function if present pre-operatively
2 It is tolerable as quantified by duration of compliance with use
3 It is efficacious as defined by nonzero improvement with respect to preoperative baseline gait stability as quantified by Dynamic Gait Index DGI and vestibulo-ocular reflex gain during passive head impulse rotation VHITG
1 It is safe as determined by incidence of serious unanticipated adverse device-related events and as further quantified by proportions of
1 implanted ears with preservation of 4-frequency pure tone average for 05124 kHz air-conducted audiometric detection thresholds 50 decibel dB HL and ear-specific speech discrimination 50 consistent with Class A or B per American Academy of Otolaryngology-Head and Neck Surgery 1995 guidelines 13 or 30 dB change from preoperative baseline if preoperative baseline is 20 dBHL and ear-specific speech discrimination 30 worse than preoperative baseline if preoperative baseline is 80
2 participants with preservation of useful sound-field hearing by the above criteria and
3 implanted ears with preservation of otolith endorgan function if present pre-operatively
2 It is tolerable as quantified by duration of compliance with use
3 It is efficacious as defined by nonzero improvement with respect to preoperative baseline gait stability as quantified by Dynamic Gait Index DGI and vestibulo-ocular reflex gain during passive head impulse rotation VHITG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None