Actively Recruiting
Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction
Led by Johns Hopkins University · Updated on 2026-01-12
8
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
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 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.
CONDITIONS
Official Title
Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 22 to 90 years with ototoxic, idiopathic, or non-ototoxic/non-central bilateral vestibular hypofunction not responsive to vestibular rehabilitation for over 1 year
- Hearing in the candidate ear is equal to or worse than the other ear
- Contralateral ear hearing allows functional communication with pure-tone average better than 70 dB HL and sentence and word recognition scores above 60%
- Severe or profound bilateral loss of labyrinthine function confirmed by caloric testing
- Prior MRI showing patent labyrinth, vestibular and cochlear nerves, and absence of tumors or central causes of dysfunction
- Prior CT showing normal facial nerve canal, middle ear without chronic disease, well-aerated mastoid cavity, skull thickness ≥3 mm, and scalp soft tissue thickness ≥7 mm
- Up-to-date vaccinations per recommended protocols to reduce meningitis risk
- Motivation to travel to the study center and participate in testing and vestibular rehabilitation exercises
- Agreement to avoid swimming and operating vehicles or heavy machinery during the study and for at least one 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, cervical spine instability, or ear canal malformations preventing testing
- Diagnosis of acoustic neuroma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibular dysfunction
- Vestibular dysfunction caused by conditions other than labyrinthine injury due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic hair cell defects
- Lack of labyrinth or vestibular nerve patency on MRI
- Contraindications to surgery, anesthesia, device use, or study assessments including material intolerance
- Recent heart attack, coronary surgery, or intervention within 6 months
- Severe orthopedic, neurologic, or other nonvestibular conditions affecting balance tests
- Severe kidney impairment (GFR <30 ml/min)
- Advanced heart failure or severe liver disease
- Untreated or unstable psychiatric conditions or substance abuse
- Contraindications to eye movement testing or intolerance of baseline tests
- Recent corneal injury or cervical spine disease preventing head rotation
- History of fainting with eye manipulations
- Pregnancy or unwillingness to use highly effective contraception during study participation
- Nursing or lactating women
- Any medical condition likely to interfere with participation or cause serious adverse events as judged by investigators
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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