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Enrolling by invitationNCT04890132Updated Mar 16, 2023

Vestibular Precision: Physiology & Pathophysiology

An interventional study of VOR precision training in Vestibular Schwannoma, Inner Ear Disease and Dizziness, sponsored by Massachusetts Eye and Ear Infirmary. Enrolling by invitation at 1 site in United States. Open to participants aged 8 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-16.

Primary conditionNeurofibromatosis 2Registry: Neuroma, AcousticReclassifiedWhy we changed it
Registry
Neuroma, Acoustic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neurofibromatosis 2
Why
  1. The study's listed conditions name Neurofibromatosis 2, a narrower term within Neuroma, Acoustic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 10 months after the study started (first participant enrolled Jul 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
8 Years to 80 Years
Sex
All
01

Study summary

This project will investigate the role of noise in the vestibular system, and in particular its effects on the variability (precision) of vestibular-mediated behaviors. The investigators will study vestibular precision in normal subjects and patients with peripheral vestibular damage, and will investigate its potential plasticity. The goals are to develop a better understanding of the role noise plays in the vestibular system in normal and pathologic populations, and to determine if the brain can learn to improve signal recognition within its inherently noisy neural environment, which would result in improved behavioral precision.

Read the detailed description

The goal of this study is to investigate vestibular precision by quantifying the variability in behavioral responses that result from the neural noise inherent to the peripheral and central vestibular systems. Because neural noise contaminates the signals that are transduced by the ear and processed by the brain, vestibular-mediated behavioral responses vary even when identical stimuli are provided. In this study, the investigators focus on vestibular precision in human subjects and investigate its sources, its effects on behavior, and its degradation when the periphery is damaged and its potential plasticity. Specifically, the investigators will investigate: (1) Vestibular precision in normal subjects - physiology: A) The investigators will measure the angular and linear vestibulo-ocular reflex (VOR) using novel motion combinations that reinforce or cancel eye movement responses, which will allow us to determine the distribution and magnitude of noise produced in the sensory (canal, otolith) pathways and in the oculomotor pathway. The investigators hypothesize that normal subjects will demonstrate a bimodal distribution of noise with either sensory or motor predominance, and that subjects with more sensory noise will demonstrate other behavioral characteristics that reflect this characteristic (e.g., higher perceptual thresholds); and B) The investigators will assay vestibular noise from trial-trial variations in the VOR and will compare VOR dynamics with those predicted by a Bayesian model using the assayed noise. The investigators predict variations in VOR dynamics across subjects, age and stimulus amplitudes will be consistent with Bayesian processing of noise. Potential confounding factors will be carefully controlled, including attention, fatigue, and non-vestibular cues. (2) Vestibular precision after peripheral damage - pathophysiology: A) The investigators will examine the changes in vestibular precision that occur when one vestibular nerve is damaged (by a vestibular schwannoma, VS) and after the damaged nerve is surgically sectioned, and will investigate if precision measurements can provide evidence of pathologic noise produced by the damaged nerve and therefore help predict clinical outcome when the nerve is sectioned. The investigators hypothesize that changes in signal reliability due to the VS will be traceable to both the reduced redundancy caused by loss of afferent fibers and to aberrant noise generated by the damaged vestibular nerve and that changes in precision after neurectomy will correlate the outcome measures that characterize patient disability; and B) The investigators will examine the plasticity of vestibular precision in the oculomotor and perceptual realms with the goal of determining if precision can be improved. Using novel training approaches that provide challenging signal extraction tasks, the investigators hypothesize that participants will improve their vestibular precision on the trained task. As secondary outcome measures, the investigators will determine if training one behavior generalizes to the non-trained behavior and if patient's symptoms are affected by improved precision.

02

Conditions studied

  • Vestibular Schwannoma
  • Inner Ear Disease
  • Dizziness
  • Neurofibromatosis 2
  • Vestibular Disorder

Keywords

  • VOR variability
  • Vestibular Precision
  • Neural Noise
  • Motion Perception
  • Perceptual Precision
  • Vestibular Ocular Reflex
03

In context

Neurofibromatosis 2 Reclassified

47 studies on the registry are indexed under Neurofibromatosis 2; 10 are open to participants now.

This study's planned enrollment of 90 is above the median of 21 across 36 interventional studies indexed under Neurofibromatosis 2.

Browse Neurofibromatosis 2 studies →

Lead sponsor

Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Compared within Neurofibromatosis 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuroma, Acoustic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
8 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Normal subjects:

  • normal vestibular-oculomotor exams
  • normal low-frequency standard rotational testing
  • normal hearing

Vestibular Schwannoma:

  • existence of unilateral vestibular schwannoma (pre \& post surgical resection)
  • must have sub-occipital surgical approach with complete sectioning of the vestibular nerve
  • rotational testing to assess pre-surgical vestibular function
  • audiogram
  • brain MRI consistent with vestibular schwannoma
  • audiography in each ear

Exclusion criteria

Exclusion Criteria:

Normal subjects

  • history of otologic or neurologic disease
  • on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)

Vestibular Schwannoma

  • other otologic disease (other than presbycusis) or any neurologic disease (other than migraine)
  • on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Normal Controls

    normal control participants - no history of neurologic or inner ear disease

    Behavioral: VOR precision training

  • Experimental
    Peripheral Vestibular Dysfunction

    Patients with unilateral vestibular damage due to monophasic illness such as vestibular neuritis or vestibular schwannoma (VS). For VS patients, the investigators will test them in three states: pre-op, sub-acute post-op (6 weeks), and chronic post-op (6 months).

    Behavioral: VOR precision training

Interventions

  • BehavioralVOR precision training

    Subjects are rotated in yaw using a pseudo-random sum of sines motion (0.5 - 2.0 Hz), view a monitor 1 m away, and are instructed to move their avatar through a maze using a joystick. The size of the maze becomes smaller in real-time when they are successful so that the patient is at the limit of their acuity. This task requires patients to optimize dynamic visual acuity to threshold-level images while rotating. We predict that VOR precision will gradually improve during training and that after training VOR precision will be better than the pre-training data. The sham task is as above but the acuity required to see the maze will set at a much larger level so baseline visual precision will be adequate to perform the task easily.

06

What researchers measure

Primary outcomes

  1. Change in perceptual thresholds

    Measurements of motion perception thresholds (yaw for rotational tasks, roll tilt for tilt task) before and after training.

    Time frame: baseline and post-training (1 hour)

  2. Change in rapid measure of gait

    This measure is scored before and after VOR precision training in UVD (unilateral vestibular dysfunction) patients. Gait is scored by performance on a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

    Time frame: baseline and post-training (1 hour)

  3. Change in measure of inducible dizziness

    Looking at the change between before and after VOR precision training in UVD (unilateral vestibular dysfunction) patients. Inducible dizziness is the symptom severity provoked by a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

    Time frame: baseline and post-training (1 hour)

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04890132
Responsible party
Richard Lewis (Associate Professor, Otolaryngology and Neurology; Director, Jenks Vestibular Laboratory, Massachusetts Eye and Ear Infirmary., Massachusetts Eye and Ear Infirmary) — Principal investigator
First posted
May 18, 2021
Start date
Jul 1, 2020
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 16, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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