What is the mechanism of action of this treatment?

Virtual reality (VR) vestibular exercises work by providing controlled visual stimuli and precise measurement of exercise performance, which are crucial for patients with vestibular disorders. The controlled visual environment helps to reduce the discomfort caused by moving objects and distracting backgrounds, making it easier for patients to perform exercises. By simulating various visual and spatial scenarios, VR can help retrain the brain to better process sensory information, thereby improving balance and reducing dizziness. Additionally, the ability to measure exercise performance accurately allows for tailored therapy that can be adjusted based on the patient's progress, ensuring more effective and personalized treatment.

What side effects are associated with this type of intervention?

Common treatments for vestibular disorders, such as virtual reality (VR) vestibular exercises, generally aim to improve balance and reduce dizziness through controlled visual stimuli and measured exercise performance. Known side effects of these treatments can include temporary dizziness, nausea, and headaches, particularly during the initial stages as the body adjusts to the exercises. These side effects are usually mild and tend to diminish as the therapy progresses. Other non-pharmacologic treatments, like standard vestibular rehabilitation exercises, may also cause similar side effects, including fatigue and imbalance during or after sessions.

What prior FDA approvals exist?

FDA-approved treatments for vestibular disorders primarily include medications such as meclizine, dimenhydrinate, and diazepam, which are used to manage symptoms like vertigo and nausea. Additionally, vestibular rehabilitation therapy (VRT) is a common non-pharmacological approach that involves specific exercises to improve balance and reduce dizziness. While the use of virtual reality for vestibular rehabilitation is an emerging field, it has not yet received specific FDA approval. Current research, including trials on VR vestibular exercises, aims to enhance traditional VRT by providing controlled visual stimuli and precise exercise performance measurements.

What other types of research exist?

Promising novel alternatives to Virtual Reality Vestibular Exercises for vestibular disorder patients include: 1) Augmented Reality (AR) Vestibular Exercises, which overlay digital information onto the real world to provide controlled visual stimuli and interactive exercises. 2) Wearable Balance Training Devices, which use sensors and feedback mechanisms to improve balance and vestibular function through real-time data. 3) Biofeedback Therapy, which uses real-time physiological data to help patients control and improve their vestibular responses. 4) Robotics-Assisted Vestibular Rehabilitation, which employs robotic devices to guide and measure precise movements and exercises.

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Virtual Reality Vestibular Rehabilitation for Vestibular Disorders (VRVR Trial)

N/A

Recruiting

Led By Karen Goodman, DPT

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

immunocompromised state from a solid organ transplant

Current symptoms of benign paroxysmal positional hypofunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 0 to 12 weeks

Awards & highlights

Summary

This trial uses a VR headset to help people with dizziness from vestibular disorders do specific exercises. The VR device shows visual scenes to make the exercises more comfortable and effective. The study aims to find the right amount of exercise needed to improve symptoms. Virtual reality-based therapy has been recently studied and shown to improve symptoms in patients with vestibular disorders.

Who is the study for?

This trial is for people with dizziness due to vestibular disorders and healthy volunteers without dizziness. It's not for those with severe obesity, recent concussion, chronic kidney disease, heart issues, stroke history, or on certain medications affecting balance/eye movements.

What is being tested?

The study tests how well virtual reality (VR) exercises improve symptoms compared to standard exercises in individuals with vestibular disorders. Participants will use a VR device that controls visual input during exercise to find the right type and dose of therapy.

What are the potential side effects?

Potential side effects may include temporary increased dizziness or nausea from the VR exercises. Since this involves physical activity, there might also be a risk of fatigue or discomfort associated with exercise.

Eligibility Criteria

Exclusion Criteria

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

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I am immunocompromised due to a solid organ transplant.

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I experience sudden, brief spells of dizziness.

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I have had a stroke before.

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My BMI is 40 or higher, indicating severe obesity.

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I have been diagnosed with heart disease or cardiomyopathy.

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I have COPD.

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I have chronic kidney disease.

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I have sickle cell disease.

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I have a disease affecting my nerves or eye movements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 0 to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 0 to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Dizziness Handicap Inventory from baseline to end of treatment

Change in Head Impulse Test from baseline to end of treatment

Secondary outcome measures

Change in Functional Gait Assessment from baseline to end of treatment

Change in Visual Vertigo Analogue Scale from baseline to end of treatment

Change in modified Clinical Test of Sensory Integration and Balance (mCTSIB) from baseline to end of treatment

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Home Exercises Using Virtual Reality DeviceExperimental Treatment1 Intervention

Participants in this arm will perform typical PT in the clinic, but will use the virtual reality device as part of their HEP.

Group II: Usual Vestibular Rehabilitation CareActive Control1 Intervention

Participants in this arm will perform typical PT in the clinic and home environment. They will be asked to keep a log to track their HEP.

Group III: Healthy ControlActive Control1 Intervention

Age-matched healthy control subjects will perform all balance, gait, vestibular, and patient reported outcome measure assessments, including performing 30 seconds of each level of gaze stability exercise for an active comparison to outcomes obtained to those with vestibular disorders.

0 / 9Eligibility 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

Virtual reality (VR) vestibular exercises work by providing controlled visual stimuli and precise measurement of exercise performance, which are crucial for patients with vestibular disorders. The controlled visual environment helps to reduce the discomfort caused by moving objects and distracting backgrounds, making it easier for patients to perform exercises. By simulating various visual and spatial scenarios, VR can help retrain the brain to better process sensory information, thereby improving balance and reducing dizziness. Additionally, the ability to measure exercise performance accurately allows for tailored therapy that can be adjusted based on the patient's progress, ensuring more effective and personalized treatment.