Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
NCT04196933 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-04-16
Summary
Multiple sensory cues are typically generated by discrete events, and while they do not reach the cerebrum simultaneously, the brain can bind them temporally if they are interpreted as corresponding to a single event. The temporal binding of vestibular and non-vestibular sensory cues is poorly understood and has not been studied in detail, despite the fact that the vestibular system operates in an inherently multimodal environment. In this study, the researchers are investigating the physiology and pathophysiology of vestibular temporal binding by studying normal subjects, patients with peripheral and central vestibular dysfunction, and patients with vestibular and cochlear signals provided by prosthetic implants in the inner ear.
Conditions
- Migraine
- Vestibular Migraine
- Vestibular Schwannoma
- Motion Sickness
- Dizziness
- Vestibular Disorder
Interventions
- BEHAVIORAL
-
Temporal Binding Adaptation - PSS training
After the PSS and TBW are calculated with the standard TOJ paradigm, 100 training trials are provided where the SOA is set to a PSS slightly greater than what was the mean calculated for normal subjects, with the goal of shifting the PSS in a direction associated with better clinical vestibular parameters and vestibular precision measurements (e.g. standard rotational testing VOR time constant, lower DHI, higher FGA score) . Then the TOJ task will be repeated but every 10 testing trials will be followed by 10 training trials (SOA = PSS desired or mean normal PSS), and this pattern will be repeated 10 times to 100 more training trials interspersed with the Post TOJ data. Subjects will respond after all trials and testing and training will not be distinguished. After this is completed, the new PSS and TBW are calculated. Sham PSS training will be identical to the above except that the 'training' period will consist of random SOAs rather than a series of fixed SOAs.
- BEHAVIORAL
-
Temporal Binding Adaptation - PSS adaptation with VI stimulation
The adaptation will utilize the same approach used in non-implanted patients. The investigators will provide a repeated, fixed SOA with either the CI or VI leading the other stimulus by 220 ms. After the training period, which will match the number of stimuli pairs provided to our normal vestibular-auditory control subjects undergoing PSS adaptation, the TOJ study is repeated to recalculate the PSS and TBW.
- BEHAVIORAL
-
Chronic Motion-modulated Stimulation
To provide 8 hours of 'physiologic' CI and VI inputs during normal activities, the investigators will employ standard motion-modulated stimulation with the VI. This requires pre-adaptation to a 200 pps tonic stimulation rate (to emulate the push-pull design of the native vestibular system allowing modulating stimulation upward or downward with opposite directions of motion). The three electrodes are connected to the head-mounted prosthetic circuit, which consists of three angular velocity sensors (one aligned with the sensitive axis of each canal) such that head rotations in the plane of the given canal modulate the stimulation rate of the corresponding electrode, upward (for ipsi) or downward (for contralateral) head rotations, thereby simulating normal canal-mediated modulations.
Sponsors & Collaborators
-
National Institute on Deafness and Other Communication Disorders (NIDCD)
collaborator NIH -
Oregon Health and Science University
collaborator OTHER -
University of Geneva, Switzerland
collaborator OTHER -
Massachusetts Eye and Ear Infirmary
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-09-05
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- United States
Study Locations
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