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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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 hour post 8-hour vi-ci 'physiologic' stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 hour post 8-hour vi-ci 'physiologic' stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Motion Sickness (MS) Susceptibility
Change in Point of Subjective Simultaneity (PSS)
Change in measure of inducible dizziness
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
102 Previous Clinical Trials
115,250 Total Patients Enrolled
2 Trials studying Vestibular Disorder
52 Patients Enrolled for Vestibular Disorder
Massachusetts Eye and Ear InfirmaryLead Sponsor
111 Previous Clinical Trials
12,387 Total Patients Enrolled
4 Trials studying Vestibular Disorder
262 Patients Enrolled for Vestibular Disorder
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
181,586 Total Patients Enrolled
2 Trials studying Vestibular Disorder
90 Patients Enrolled for Vestibular Disorder
Oregon Health and Science UniversityOTHER
1,008 Previous Clinical Trials
7,413,717 Total Patients Enrolled

Media Library

Chronic Motion-modulated Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04196933 — N/A
Vestibular Disorder Research Study Groups: Normal Controls, Central Vestibular Dysfunction, Peripheral Vestibular Dysfunction, Implant Subjects
Vestibular Disorder Clinical Trial 2023: Chronic Motion-modulated Stimulation Highlights & Side Effects. Trial Name: NCT04196933 — N/A
Chronic Motion-modulated Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04196933 — N/A
~76 spots leftby Dec 2025