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Virtual Reality Therapy for Vertigo (VR-PVD-RCT Trial)

N/A

Recruiting

Led By Desmond A Nunez, MD, MBA

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Diagnosis made using caloric testing (≥25% reduced vestibular response) and either ocular vestibular evoked myogenic potential (oVEMP) or cervical vestibular evoked myogenic potential (cVEMP) testing

Participants ≥18 years of age

Must not have

Participant diagnosed with a central vestibular disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the ssq will be completed at the baseline visit and every day of the home exercise program or virtual reality game intervention which can range from 28 days to 56 days depending on laterality of the peripheral vestibular disorder.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if the location of the inner ear problem affects how well virtual reality therapy works for patients. Fifty patients will be recruited from a neurotology clinic and split into two groups.

Who is the study for?

This trial is for adults over 18 with chronic peripheral vestibular disorders like vertigo or Meniere's Disease, diagnosed using specific tests. They must have had the condition for at least 3 months and be prescribed vestibular rehabilitation. Participants need to have access to a smartphone.

What is being tested?

The study compares standard vestibular rehab with two additions: auditory intervention and at-home VR therapy, to see if VR helps improve symptoms based on where the disorder is located in the ear. Patients are randomly placed into groups and follow treatment protocols for up to 8 weeks.

What are the potential side effects?

Potential side effects may include discomfort from wearing VR headsets, dizziness or nausea due to virtual reality experiences, headaches, eye strain, or temporary increase in vertigo symptoms during adaptation.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis was confirmed with specific balance tests.

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I am 18 years old or older.

Exclusion Criteria

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

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I have been diagnosed with a balance disorder related to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the ssq will be completed at the baseline visit and every day of the home exercise program or virtual reality game intervention which can range from 28 days to 56 days depending on laterality of the peripheral vestibular disorder.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the ssq will be completed at the baseline visit and every day of the home exercise program or virtual reality game intervention which can range from 28 days to 56 days depending on laterality of the peripheral vestibular disorder.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the ssq will be completed at the baseline visit and every day of the home exercise program or virtual reality game intervention which can range from 28 days to 56 days depending on laterality of the peripheral vestibular disorder. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dizziness Handicap Inventory (DHI) score

Secondary study objectives

Activities-specific Balance Confidence (ABC) score

Other study objectives

Simulator Sickness Questionnaire (SSQ) score

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

Active Control

Group I: Virtual Reality GroupExperimental Treatment1 Intervention

Patients have baseline data collected two weeks pre-intervention by assessing patient symptomatology using the dizziness handicap inventory, activities specific balance confidence questionnaires and a simulator sickness questionnaire remotely. Next, an interview will be conducted to collect information including age, sex, ethnicity, physical activity level and VR experience. Lastly, VR headset will be mailed to patients home address. A date for VR device tutorial will be discussed during this interview. Next patients will undergo 4 or 8 weeks of vestibular rehabilitation if diagnosed with unilateral or bilateral vestibular hypofunction respectively. This involves weekly 40-45 minute in-person sessions with a physiotherapist and three 20 minute sessions a day of at-home independent exercises. In addition, they will undergo an at home VR vestibular rehabilitation protocol that involves playing a video game projected on an android or apple device in a VR headset for 20 minutes daily.

Group II: Control GroupActive Control1 Intervention

Patients have baseline data collected two weeks pre-intervention by assessing patient symptomatology using the dizziness handicap inventory, activities specific balance confidence questionnaires and a simulator sickness questionnaire remotely. Next, an interview will be conducted to collect information including age, sex, ethnicity, physical activity level and VR experience. Next patients will undergo 4 or 8 weeks of vestibular rehabilitation if diagnosed with unilateral or bilateral vestibular hypofunction respectively. This involves weekly 40-45 minute in-person sessions with a physiotherapist and three 20 minute sessions a day of at-home independent exercises. In addition, they will undergo an at-home regime that consists of auditory stimulation while wearing a VR headset for 20 minutes daily.

0 / 3Eligibility criteria met