What side effects are associated with this type of intervention?

Common treatments for vestibular disorders include vestibular rehabilitation therapy (VRT), which generally has minimal side effects but may cause temporary dizziness or imbalance as the body adjusts. Medications such as vestibular suppressants (e.g., meclizine, diazepam) can cause drowsiness, dry mouth, and blurred vision. In some cases, surgical interventions are used, which carry risks of infection, hearing loss, and persistent dizziness. These treatments aim to improve vestibular function and reduce symptoms, but side effects vary depending on the specific treatment and individual patient response.

What prior FDA approvals exist?

FDA-approved treatments for vestibular disorders typically include medications such as antihistamines, benzodiazepines, and anticholinergics, which are used to manage symptoms like vertigo and nausea. These treatments do not specifically target neural plasticity or the precision of vestibular-mediated behaviors, which are the focus of the current trial on noise exposure and vestibular precision. The trial aims to explore novel approaches to improve signal recognition in the vestibular system, potentially leading to new therapeutic strategies.

What other types of research exist?

Promising novel alternatives for treating vestibular disorders in 2024 include vestibular rehabilitation therapy (VRT), which uses specific exercises to improve balance and reduce dizziness, and virtual reality (VR)-based rehabilitation, which provides immersive environments to enhance vestibular function. Additionally, transcranial magnetic stimulation (TMS) and vestibular implants are emerging as potential treatments to improve vestibular precision and leverage neural plasticity.

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VOR Precision Training for Vestibular Disorders

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

Vestibular Schwannoma: rotational testing to assess pre-surgical vestibular function

Vestibular Schwannoma: must have sub-occipital surgical approach with complete sectioning of the vestibular nerve

Must not have

Vestibular Schwannoma: other otologic disease (other than presbycusis) or any neurologic disease (other than migraine)

Normal subjects: history of otologic or neurologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post-training (1 hour)

Awards & highlights

No Placebo-Only Group

Summary

This trial measures how accurately people can balance and move their eyes in response to motion, focusing on both healthy individuals and those with balance system damage. The goal is to understand the role of noise in these systems and see if training can help improve accuracy.

Who is the study for?

This trial is for people with certain inner ear conditions like Vestibular Schwannoma, requiring surgery, or healthy individuals with normal vestibular function and hearing. Participants should not have other ear or neurological diseases (except migraines) and must not be taking medication that affects the vestibular system.

What is being tested?

The study focuses on 'VOR precision training' to understand how noise impacts the balance system in both healthy subjects and those with vestibular damage. It aims to see if patients can learn to better recognize signals amidst this noise, potentially improving balance.

What are the potential side effects?

Since this trial involves non-invasive VOR precision training rather than medication or surgical intervention, side effects are minimal but may include temporary dizziness or discomfort during exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone tests to check my balance before surgery for a brain tumor.

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I had surgery for a brain tumor where the nerve affecting balance was cut.

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I have normal hearing.

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I have or had a non-cancerous tumor on the nerve used for hearing and balance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain tumor affecting my hearing but no other ear or neurological conditions.

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I have no history of ear or brain diseases.

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I am not taking any medication for dizziness.

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I am taking medication for my vestibular schwannoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post-training (1 hour)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post-training (1 hour)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-training (1 hour) 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 measure of inducible dizziness

Change in perceptual thresholds

Change in rapid measure of gait

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Peripheral Vestibular DysfunctionExperimental Treatment1 Intervention

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).

Group II: Normal ControlsExperimental Treatment1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for vestibular disorders include vestibular rehabilitation therapy (VRT), medications, and lifestyle modifications. VRT involves exercises designed to improve balance and reduce dizziness by promoting neural plasticity, helping the brain to adapt to and compensate for vestibular deficits. Medications such as antihistamines and benzodiazepines can alleviate symptoms like vertigo and nausea by dampening the vestibular system's response. Lifestyle modifications, including strategic avoidance of triggers like certain head movements or environments, can also help manage symptoms. Understanding these mechanisms is crucial for patients as it highlights the importance of consistent therapy and adherence to treatment plans to improve their quality of life and functional abilities.

Sense and Sensibility: A Review of the Behavioral Neuroscience of Tinnitus Sound Therapy and a New Typology.The Effect of Physical Therapy Treatment in Patients with Subjective Tinnitus: A Systematic Review.Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT'ID study protocol for using a Delphi process and face-to-face meetings to establish consensus.