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Vestibular Rehabilitation for Acoustic Neuroma
N/A
Waitlist Available
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 hour post 8-hour vi-ci 'physiologic' stimulation
Awards & highlights
Study Summary
This trial is studying how different vestibular and non-vestibular cues are integrated by the brain when they are perceived as corresponding to a single event.
Who is the study for?
This trial is for individuals with migraines, vestibular disorders like vertigo, or those planning cochlear implant surgery due to deafness. Participants must meet specific criteria including normal hearing and vestibular function tests, and not have had a migraine or vestibular episode in the last two weeks. Pregnant women, people on certain medications, or those with other neurological conditions are excluded.Check my eligibility
What is being tested?
The study explores how the brain combines different sensory signals related to balance and movement. It includes patients with various conditions affecting balance (vestibular disorders) as well as healthy subjects. The interventions involve specialized training techniques designed to improve the brain's ability to process these signals.See study design
What are the potential side effects?
Since this trial focuses on non-invasive training techniques rather than medication or surgical intervention, side effects may be minimal but could include temporary dizziness or discomfort during exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 1 hour post 8-hour vi-ci 'physiologic' stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 hour post 8-hour vi-ci 'physiologic' stimulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Motion Sickness (MS) Susceptibility
Change in Point of Subjective Simultaneity (PSS)
Change in measure of inducible dizziness
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Peripheral Vestibular DysfunctionExperimental Treatment2 Interventions
Vestibular Schwannoma patients
The basic approach is to characterize the precision of their vestibular information (perceptual thresholds for spatial precision, reaction times for temporal precision), and their temporal binding characteristics for vestibular (yaw rotation or y-translation)-visual inputs, in three states: pre-op, sub-acute post-op (2-6 weeks), and chronic post-op (6 months+). At each state the investigators will also assess the quality of their vestibular-mediated behaviors through questionnaires (e.g. DHI), postural sway, functional gait analysis, and standard rotational testing (VOR gain, time constant, and asymmetry).
Group II: Normal ControlsExperimental Treatment2 Interventions
normal control subjects - no history of neurologic or inner ear disease
The investigators will characterize vestibular spatial and temporal precision by calculating perceptual thresholds and reaction times for vestibular (yaw rotation, ytranslation) stimuli in normal subjects over a wide age range. Vestibular-visual temporal binding is then performed on each subject and the relationship between the principal parameters (vestibular perceptual thresholds [inversely related to spatial precision], vestibular reaction time variability [inverse of temporal precision], and the PSS and TBW from the temporal binding paradigm) will be examined. The investigators will collect qualitative assessments of dizziness/disbalance (DHI: dizziness handicap index) and quantitative measurements of balance and vestibular function (FGA: functional gait analysis, postural sway, and standard rotational testing - VOR gain, time constant, asymmetry).
Group III: Implant SubjectsExperimental Treatment2 Interventions
Cochlear Implant (CI)/Vestibular Implant (VI) patients
A causative role for vestibular precision in temporal binding will be investigated in the VI patients, since the noise characteristics of the vestibular channel will be varied and to determine how this affects thresholds and temporal binding. As part of a second aim, the investigators will use VI and CI prosthetic signals in patients who have never received them together to see how the brain process sensory cues to which it is essentially naïve. Finally, after the acute experiments the investigators will provide 8 hours of 'physiologic' VI and CI stimulation by turning both implants on, sound modulates activity in the CI as usual, and angular head motion modulates activity in the VI while the subject actively explores the hospital environment.
Group IV: Central Vestibular DysfunctionExperimental Treatment2 Interventions
Migraine and Vestibular Migraine patients
The investigators intend to evaluate vestibular (yaw rotation or y-translation) - visual temporal binding in people with a wide range of motion sickness sensitivities (as quantified with standard questionnaires), including normal subjects, people with migraine and with vestibular migraine. The investigators will use our standard adaption method to narrow the TBW in these subjects, and will also employ PSS adaptation if a consistent pattern emerges that relates MS sensitivity to the PSS. The investigators will induce motion sickness using a pseudo-Coriolis task (so susceptibility can be quantified pre and post training).
Find a Location
Who is running the clinical trial?
University of Geneva, SwitzerlandOTHER
97 Previous Clinical Trials
114,637 Total Patients Enrolled
2 Trials studying Vestibular Disorder
70 Patients Enrolled for Vestibular Disorder
Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,477 Total Patients Enrolled
3 Trials studying Vestibular Disorder
160 Patients Enrolled for Vestibular Disorder
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
177,824 Total Patients Enrolled
2 Trials studying Vestibular Disorder
90 Patients Enrolled for Vestibular Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with migraines who fit the specific rules for migraines and have not had a migraine in the past two weeks.You have migraines and have experienced certain symptoms related to balance or dizziness, or are taking specific medications for migraines or balance issues.People who have vestibular migraine and are taking certain medications for migraine prevention or to suppress dizziness.You have passed tests for balance, eye movement, and hearing.You have vestibular migraines that match specific criteria, including having balance issues during migraines, and are being tested more than 2 weeks after your last migraine or balance episode.People who are going to have surgery to get a cochlear implant because they have been deaf for at least 5 years and meet specific hearing and balance criteria.You are a healthy person without a history of ear or brain problems, not taking certain medications, and not pregnant or recently pregnant.You have a vestibular schwannoma and any other ear or neurological conditions, or if you are taking medication that affects your balance.You have a specific type of tumor in your ear and are planning to have surgery to remove it, and you meet certain testing and imaging requirements.People who do not have any medical conditions.You have regular hearing.You have had a migraine headache within the past two weeks.You have passed exams for your balance and eye movements.You have symptoms that match the guidelines for migraine headaches set by the International Headache Society.You have normal results from a specific type of balance test.
Research Study Groups:
This trial has the following groups:- Group 1: Normal Controls
- Group 2: Central Vestibular Dysfunction
- Group 3: Peripheral Vestibular Dysfunction
- Group 4: Implant Subjects
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.
Can individuals below the age of 50 partake in this experiment?
"In order to be eligible for this investigation, patients must between 18 and 80 years old. Additionally, there are 43 trials available to those under the age of majority while 183 studies are open to seniors aged 65 or older."
Answered by AI
Is participation in this investigation available to the general public?
"This clinical trial is not taking on more participants presently, as the most recent update was published on September 21st 2021. Despite this, there are 245 other trials actively recruiting patients."
Answered by AI
Is it possible to enlist in this research project?
"This trial is looking to recruit 472 individuals with airsickness, between 18 and 80 years of age. To be eligible as a participant, these criteria must both be met."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
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