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Device
Vestibular Implant for Bilateral Vestibulopathy
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
Adults age 22-90 years diagnosed with ototoxic, idiopathic or non-ototoxic/non-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders
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 studies a device to help those w/ non-ototoxic vestibular hypofunction to improve posture & vision, reduce disability & improve quality of life.
Who is the study for?
Adults aged 22-90 with severe bilateral vestibular hypofunction, which causes chronic imbalance and vision issues, are eligible. They must have specific imaging results showing no central nervous system causes for their condition, be motivated for rehabilitation exercises, not swim or operate dangerous machinery during the study, and agree to recommended vaccinations. Pregnant or nursing women and those with certain medical conditions like acoustic neuroma are excluded.Check my eligibility
What is being tested?
The trial is testing the Labyrinth Devices MVI™ Multichannel Vestibular Implant System on individuals who haven't responded well to other treatments for balance disorders caused by inner ear problems. It's a single-arm open-label study aiming to improve stability and quality of life in up to fifteen adults.See study design
What are the potential side effects?
Potential side effects may include loss of residual hearing in the implanted ear, altered sensation around the implant site, device failure requiring replacement or removal, dizziness during initial activation or adjustment periods, and possible risk of meningitis despite vaccination.
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 and balance issues.
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I am between 22-90 years old with a balance disorder not improved by therapy for over a year.
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My CT scans show normal ear structures suitable for surgery.
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 8 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System
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Who is running the clinical trial?
Labyrinth Devices, LLCOTHER
2 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Bilateral Vestibular Hypofunction
15 Patients Enrolled for Bilateral Vestibular Hypofunction
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,463 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,489 Total Patients Enrolled
1 Trials studying Bilateral Vestibular Hypofunction
15 Patients Enrolled for Bilateral Vestibular Hypofunction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain MRI showed no tumors or causes for hearing and balance issues.I am between 22-90 years old with a balance disorder not improved by therapy for over a year.I have been diagnosed with a specific ear or brain condition affecting my balance or hearing.My CT scans show normal ear structures suitable for surgery.I have received all recommended vaccinations to lower meningitis risk before my cochlear implant surgery.My balance issues are not due to inner ear damage.The ear that would be implanted needs to have worse or equal hearing compared to the other ear, and the other ear needs to have good enough hearing for communication in case the implanted ear loses its hearing after the implantation.I understand the procedures and risks involved in the study as explained to me.I cannot perform required study activities due to physical limitations.You have severe or complete 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.
Does this research involve individuals aged 45 or older?
"The age requirements for this trial are quite expansive, ranging from 22 to 90 years old."
Answered by AI
Are there any age or health restrictions for participating in this research?
"This clinical trial is looking to accept 8 patients with bilateral vestibulopathy aged between 22 and 90 years old."
Answered by AI
Are there any vacancies left for individuals who would like to join this research?
"The clinicaltrials.gov website shows that this medical study, which was published on January 1st 2023 and updated most recently on May 5th same year, is not currently recruiting patients. Nevertheless, there are 930 other trials actively seeking participants at the moment."
Answered by AI
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