Actively Recruiting
Vestibular Implantation in Older Adults
Led by Johns Hopkins University · Updated on 2026-01-12
15
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vestibular Implantation in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 65 to 90 years diagnosed with ototoxic, idiopathic, or non-ototoxic/non-central bilateral vestibular hypofunction unresponsive to vestibular rehabilitation for over 1 year
- Hearing in the ear to be implanted is equal to or worse than the opposite ear
- Contralateral ear has better than 70 dB HL pure-tone average at 0.5/1/2/4 kHz
- Contralateral ear has ear-specific sentence recognition score over 60% on AzBio test at 60 dB SPL-A in quiet
- Contralateral ear has ear-specific word recognition score over 60% on CNC test at 60 dBHL in quiet
- Severe or profound bilateral loss of labyrinthine function confirmed by caloric testing criteria
- Prior MRI showing patent labyrinth, present vestibular and cochlear nerves, and no tumors or central causes of dysfunction
- Prior CT showing normal facial nerve canal, no middle ear disease, adequate mastoid aeration, skull thickness ≥3 mm, and scalp soft tissue thickness ≥7 mm
- Up-to-date vaccinations to reduce meningitis risk per CDC and Johns Hopkins protocols
- Motivated to travel to study center, undergo testing, and participate in vestibular rehabilitation exercises
- Agreement to avoid swimming and operating vehicles, heavy machinery, or powered tools during the study and for 1 month after device deactivation
You will not qualify if you...
- Inability to understand study procedures and risks
- Inability to participate due to blindness, limited neck motion (≤ ±10°), cervical spine instability, or ear canal malformations preventing caloric testing
- Diagnosis of acoustic neuroma, vestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction
- Vestibular dysfunction from causes other than ototoxicity, ischemia, trauma, infection, Meniere's disease, or known genetic hair cell defects
- Lack of labyrinth patency or vestibular nerve on MRI
- Contraindications to surgery, anesthesia, device activation/deactivation, or study assessments
- History of myocardial infarction, coronary bypass, or percutaneous coronary intervention within 6 months before screening
- Severe orthopedic, neurologic, or other conditions affecting posture or gait testing
- Estimated glomerular filtration rate (GFR) below 30 ml/min at screening
- Heart failure NYHA class III or IV
- Child-Pugh class C cirrhosis
- Untreated or unstable depression, suicidality, psychiatric disease, or substance abuse interfering with compliance
- Contraindications to scleral coil eye movement testing including monocular blindness or fainting history
- Inability to tolerate baseline testing
- Recent corneal injury
- Cervical spine disease preventing head rotation
- History of fainting or vagal reactions before eye manipulations
- Pregnancy or positive pregnancy test during study
- Women able to become pregnant who do not use highly effective contraception from 1 month before implantation until 1 month after device deactivation and study completion
- Nursing or lactating women
- Any medical condition judged to interfere with participation or cause serious adverse events during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
K
Kelly Lane (Study Coordinator)
CONTACT
C
Charles C Della Santina MD, PhD, (Lead Surgeon)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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