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Vestibular Implant
Vestibular Implant for Age-Related Hearing Loss
N/A
Recruiting
Led By John P Carey, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present cochlear nerve, and absence of internal auditory canal/cerebellopontine angle tumors or other central causes of vestibulo-ocular reflex dysfunction or sensorineural hearing loss
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 3 weeks post-implantation to 6 months post-implantation
Awards & highlights
Study Summary
This trial aims to assess a new device to improve balance, vision and gait in elderly adults with hearing loss caused by vestibular hypofunction.
Who is the study for?
This trial is for older adults aged 65-90 with severe balance and vision issues due to bilateral vestibular hypofunction, who haven't improved after a year of rehab. They must be vaccinated per certain protocols, have specific hearing levels, agree not to swim or use heavy machinery during the study, and be able to travel for tests and exercises.Check my eligibility
What is being tested?
The Labyrinth Devices MVI™ Multichannel Vestibular Implant System is being tested in this single-arm open-label study. It aims to restore vestibular reflexes which help maintain steady posture and vision in those suffering from chronic imbalance due to inner ear function loss.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with surgical implantation such as infection, device malfunction or failure, altered sensation around the implant site, dizziness or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain MRI showed no tumors or causes for hearing loss or balance issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from 3 weeks post-implantation to 6 months post-implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 3 weeks post-implantation to 6 months post-implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PM1.1: Dynamic Gait Index (DGI) during motion-modulated implant stimulation at 6 months post-implantation, relative to pre-operative baseline, aggregated across all implant users.
PM1.2: Gain (VHITG) of the vestibulo-ocular reflex, as measured using the video head impulse test averaged for the three implanted semicircular canals, relative to pre-operative baseline, aggregated across all implant users.
Secondary outcome measures
EM1.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
EM1.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
EM1.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
+64 moreOther outcome measures
XM1.1 (A,B,C): Change in vestibulo-ocular reflex (VOR) latency (msec) during video head impulse testing (VHIT) at 6 months post-implantation, relative to preoperative baseline values
XM1.2 (A,B,C): Change in saccade latency (msec) during video head impulse testing (VHIT) at 6 months post-implantation, relative to preoperative baseline values
XM10.1 (A,B,C): Change in time to complete the Trail Making Test Part B (TMT)
+36 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: vestibular implantExperimental Treatment1 Intervention
Up to 15 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Find a Location
Who is running the clinical trial?
Labyrinth Devices, LLCOTHER
2 Previous Clinical Trials
38 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,150 Total Patients Enrolled
13 Trials studying Hearing Loss
4,875 Patients Enrolled for Hearing Loss
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,584 Total Patients Enrolled
9 Trials studying Hearing Loss
2,802 Patients Enrolled for Hearing Loss
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot handle the initial testing procedures.You have a history of fainting or feeling dizzy before eye tests that measure 3D eye movements.My liver disease is severe (Child-Pugh class C).You cannot have the eye movement test if you have one blind eye or have had fainting reactions to previous eye tests.I cannot turn my head due to a neck condition.You have untreated or unstable depression, have had thoughts of harming yourself, or have a history of mental illness or substance abuse that could make it hard for you to follow the study rules.I am between 65-90 years old with a balance disorder not improved by therapy for over a year.You have a blockage or problem in your inner ear or vestibular nerve, as shown by a special type of brain scan.I have recently injured my eye's cornea.My brain MRI showed no tumors or causes for hearing loss or balance issues.My balance issues are not due to inner ear damage from drugs, lack of blood flow, injury, infection, Meniere's disease, or genetic conditions.My CT scans show normal ear structures suitable for surgery.I understand the procedures and risks involved in the study as explained to me.You are pregnant or have a positive pregnancy test during the study.I have received all recommended vaccinations to lower meningitis risk before my cochlear implant surgery.I have a diagnosis affecting my inner ear or balance, possibly due to long-term substance use.I have not had a heart attack or any heart surgery in the last 6 months.I have severe heart failure.I have no known allergies or intolerances to materials in the study devices.Your hearing in the ear that will receive the implant is as bad as or worse than your other ear, and your other ear has good enough hearing for you to communicate effectively if you lose hearing in the implanted ear after the surgery.I do not have severe bone, nerve, or other conditions that could affect balance tests.I do not have severe neck, ear, or eye conditions that would prevent me from undergoing certain tests.My kidney function is low, with a GFR under 30 ml/min.You have severe or profound loss of balance function in both ears.
Research Study Groups:
This trial has the following groups:- Group 1: vestibular implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being included in the subject pool of this research endeavor?
"This clinical trial requires all participant to be between the ages 65 and 90. For patients younger than 18, there are 240 studies available while those over 65 can join 641 other trials."
Answered by AI
Are there any unfilled vacancies in this research trial?
"Confirmed. Clinicaltrials.gov does not indicate that this specific trial is currently recruiting patients, with its initial posting occurring on January 1st 2023 and the last update being made on May 5th of the same year. While no longer enrolling, 932 other clinical trials are actively seeking out potential participants at this time."
Answered by AI
Is there a way I could contribute to this trial's research?
"This clinical trial seeks 15 individuals aged 65-90 with bilateral vestibulopathy who comply to the following: possess a 0.5/1/2/4 kHz pure-tone average threshold that is lower than 70 dB HL; have at least 60% ear-specific sentence recognition score and word recognition score when presented at 60dBHL in quiet; demonstrate severe or profound labyrinthine function loss as indicated by caloric responses of <10° /sec per ear for each ear, among other criteria. Furthermore, participants must agree not to engage in activities such as swimming or operating vehicles until 1 month after deactivation of the MVI Implant"
Answered by AI
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