Vestibular SchwannomaNCT04890132
Vestibular Precision: Physiology & Pathophysiology
A study testing VOR precision training in people with Vestibular Schwannoma and Inner Ear Disease, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Schwannoma, Inner Ear Disease, Dizziness
- What is being tested?
- VOR precision training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Vestibular Schwannoma, Inner Ear Disease, Dizziness, Neurofibromatosis 2, Vestibular Disorder
- Being tested
- VOR precision training
- Keywords
- VOR variability, Vestibular Precision, Neural Noise, Motion Perception, Perceptual Precision, Vestibular Ocular Reflex
- Medical subject headings
- Neuroma, Acoustic, Labyrinth Diseases, Dizziness, Neurofibromatosis 2, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOR precision trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | Experimental | normal control participants - no history of neurologic or inner ear disease Receives: Behavioral: VOR precision training |
| Peripheral Vestibular Dysfunction | Experimental | 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). Receives: Behavioral: VOR precision training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceptual thresholds
Measurements of motion perception thresholds (yaw for rotational tasks, roll tilt for tilt task) before and after training.
Measured: baseline and post-training (1 hour)
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.
Measured: baseline and post-training (1 hour)
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.
Measured: baseline and post-training (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Lewis, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890132
- Sponsor's protocol ID
- 2019A015798
- Status last verified
- Mar 2023
- First submitted
- 12 May 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Precision: Physiology & Pathophysiology
- ClinicalTrials.gov ID
- NCT04890132
- Acronym / sponsor ID
- 2019A015798
- Conditions
- Vestibular Schwannoma, Inner Ear Disease, Dizziness, Neurofibromatosis 2, Vestibular Disorder
- Keywords
- VOR variability, Vestibular Precision, Neural Noise, Motion Perception, Perceptual Precision, Vestibular Ocular Reflex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | Experimental | Behavioral: VOR precision trainingnormal control participants - no history of neurologic or inner ear disease |
| Peripheral Vestibular Dysfunction | Experimental | Behavioral: VOR precision trainingPatients 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). |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- normal vestibular-oculomotor exams
- normal low-frequency standard rotational testing
- normal hearing
- existence of unilateral vestibular schwannoma (pre \& post surgical resection)
- must have sub-occipital surgical approach with complete sectioning of the vestibular nerve
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOR precision trainingSubjects 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. | Behavioural | Normal Controls, Peripheral Vestibular Dysfunction |
Primary outcome
Change in perceptual thresholds
Time frame: baseline and post-training (1 hour)
Measurements of motion perception thresholds (yaw for rotational tasks, roll tilt for tilt task) before and after training.
Change in rapid measure of gait
Time frame: baseline and post-training (1 hour)
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.
Change in measure of inducible dizziness
Time frame: baseline and post-training (1 hour)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOR precision training in people with Vestibular Schwannoma and Inner Ear Disease, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceptual thresholds (time frame: baseline and post-training (1 hour)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.