Vestibular Implantation in Older Adults

Vestibular Diseases Clinical Trial

Official title: Vestibular Implantation in Older Adults

Status Recruiting

Clinical Trial 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 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.

Clinical Trial Description

There is no 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 seven adults aged 51-64 years with bilateral vestibular hypofunction due to ototoxicity 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 that this approach can partially restore vestibular sensation and reflexes that normally maintain steady posture and vision. This study will extend vestibular implant treatment to older adults with idiopathic or non-ototoxic/non-central bilateral vestibular hypofunction. Within constraints on power and/or 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 (≥8 week) continuous/daily use:

1. It is feasible, as quantified by implantation being achieved in all subjects undergoing attempted implantation surgery.

2. 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 0.5,1,2,4 kHz air-conducted audiometric detection thresholds ≤ 50 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) 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

3. It is tolerable, as quantified by ≥6 mo duration of compliance with use.

4. It is efficacious, as defined by nonzero improvement with respect to preoperative baseline in Vestibular Implant Composite Outcome score, which incorporates vestibulo-ocular reflex gain during passive head impulse rotation (VHITG); postural stability as quantified by the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition Balance Subtest 5 (BOT); gait stability as quantified by Dynamic Gait Index (DGI); Dizziness Handicap Inventory (DHI); and SF-6D health utility (SF6DU) ;

Related Conditions & MeSH terms

• Bilateral Vestibular Deficiency (BVD)
• Bilateral Vestibulopathy
• Gentamicin Ototoxicity
• Labyrinth Diseases
• Labyrinthitis
• Other Disorders of Vestibular Function, Bilateral
• Ototoxicity
• Sensation Disorders
• Vestibular Diseases

• NCT number: NCT05676944
• Study type: Interventional
• Source: Johns Hopkins University
• Contact: Kelly Lane (Study Coordinator)
• Phone: 410-502-8047
• Email: vestibularimplant@jhmi.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Completion date: January 31, 2028