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Device
Vestibular Implant for Bilateral Vestibulopathy
N/A
Waitlist Available
Led By John P Carey MD (Independent/Nonconflicted IRB Protocol PI)
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hearing status criteria for candidate ear and contralateral ear
Adults age 22.0-90 with bilateral vestibular deficiency not responsive to vestibular rehabilitation as determined by pre-inclusion history, vestibular testing and clinical examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Awards & highlights
Study Summary
This trial will test whether electrical stimulation of the vestibular nerve can help people with balance problems due to inner ear dysfunction.
Who is the study for?
Adults aged 22-90 with severe balance and vision issues due to inner ear dysfunction, who haven't improved with rehab. They must be able to travel for tests and commit to a vestibular exercise regimen. Excluded are those with certain medical conditions, recent eye injuries, severe kidney problems, nursing women, or anyone unable to follow the study's procedures.Check my eligibility
What is being tested?
The trial is testing a device called the Labyrinth Devices MVI™ Multichannel Vestibular Implant in up to ten people. It aims to restore balance and stable vision in patients with bilateral vestibular deficiency by electrically stimulating the vestibular nerve.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with surgical implantation such as infection, discomfort at the implant site, possible interference with balance during initial use of the device, and any unforeseen reactions from long-term electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hearing in both ears meets the study's requirements.
Select...
I am between 22 and 90 years old with a balance disorder not improved by therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the effects of MVI implantation on cochlear function, as indicated by changes in Arizona Biomedical (AzBio) sentence recognition scores
Assess the effects of MVI implantation on cochlear function, as indicated by changes in Consonant-vowel nucleus-consonant (CNC) speech recognition scores
Assess the effects of MVI implantation on cochlear function, as indicated by changes in pure tone audiometry
+6 moreSecondary outcome measures
Change in Bruininks-Oseretsky test of motor proficiency- balance subtest 2 (BOT2) score
Berry Aneurysm
Change in Dynamic Gait Index (DGI)
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: vestibular implantExperimental Treatment1 Intervention
Up to 30 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?
Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,041 Total Patients Enrolled
2 Trials studying Bilateral Vestibular Hypofunction
23 Patients Enrolled for Bilateral Vestibular Hypofunction
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
327 Previous Clinical Trials
178,185 Total Patients Enrolled
1 Trials studying Bilateral Vestibular Hypofunction
8 Patients Enrolled for Bilateral Vestibular Hypofunction
Labyrinth Devices, LLCOTHER
2 Previous Clinical Trials
23 Total Patients Enrolled
2 Trials studying Bilateral Vestibular Hypofunction
23 Patients Enrolled for Bilateral Vestibular Hypofunction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe bone, nerve, or other non-ear related health issues.I have fainted or had a strong dizzy spell from eye procedures before.My hearing in both ears meets the study's requirements.I have no health issues preventing surgery, anesthesia, or study participation.My kidney function is low, with a GFR under 30 ml/min.I cannot rotate my head due to a neck condition.I am between 22 and 90 years old with a balance disorder not improved by therapy.I cannot perform certain physical activities required by the study.You have severe or complete loss of balance function in both ears.You have a medical reason that makes it unsafe for you to have an eye movement test using a scleral coil.I have severe heart failure.You are pregnant or have a positive pregnancy test during the study.My liver disease is severe (Child-Pugh class C).I agree not to swim or use specific devices during the study and for 1 month after.You have previously had MRI and CT scans that show specific results.You have a blockage in the inner ear or vestibular nerve, as shown by an MRI.I have been diagnosed with a condition that affects my balance.I have recently injured my eye's cornea.You cannot undergo the initial testing required for the study.
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.
What is the current enrollment quota for this clinical experiment?
"Affirmative. Clinicaltrials.gov's records show that this clinical trial, first published on April 1st 2016, is actively recruiting volunteers. 30 individuals are sought for the study at one location."
Answered by AI
What is the aim of this trial?
"The primary metric of this study, measured over a period of 1 year through visits 0-10, is to examine the influence of MVI usage on cochlear functioning as indicated by CNC speech recognition scores. Auxiliary outcomes include ascertaining the effects of MVI implantation and use on daily activities via VADL score (1 - 10; higher meaning worse outcome), gauging motor proficiency balance with BOT2 score (0 - 36; higher implying better result) and assessing the efficacy/feasibility of MVI using DVA test score in logarithmic form based off Minimum Angle Resolvable(LogMAR"
Answered by AI
Are elderly individuals being considered for enrollment in this scientific investigation?
"The minimum age for enrollment in this trial is 22 years and the maximum is 90, as specified by the eligibility criteria."
Answered by AI
Could I potentially meet the requirements to partake in this research project?
"Prerequisites for this research study stipulate that participants suffer from a vestibular disorder and must be between 22-90 years old. Thus far, 30 individuals have been enrolled in the trial."
Answered by AI
Is there still availability to join this clinical trial?
"Affirmative. The clinicaltrials.gov website attests to this trial's ongoing recruitment, which began on April 1st 2016 and was updated as recently as August 19th 2022. At present, 30 participants are needed at one location for the study."
Answered by AI
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