Virtual Reality Therapy for Vertigo

(VR-PVD-RCT Trial)

Overseen By Austin Heffernan, BMSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Pregnancy, Central vestibular disorder

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 to 8 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for vertigo?

Research shows that virtual reality-based vestibular rehabilitation can significantly improve symptoms in patients with vestibular disorders, making the treatment more enjoyable and potentially more effective than conventional therapy. Additionally, internet-based vestibular rehabilitation has been shown to reduce symptoms of dizziness and vertigo for up to 6 months. ^{1 2 3 4 5}

Is virtual reality therapy for vertigo safe for humans?

Research on virtual reality therapy for vertigo, including studies on patients with vestibular disorders, suggests that it is generally safe for humans. These studies have not reported significant safety concerns, indicating that virtual reality-based vestibular rehabilitation is a safe option for managing vertigo symptoms. ^{1 2 3 5 6}

How is the Virtual Reality Therapy for Vertigo treatment different from other treatments for vertigo?

This treatment is unique because it combines standard vestibular rehabilitation with virtual reality technology, allowing patients to perform exercises at home in an engaging and interactive way, which can enhance the rehabilitation process and potentially reduce costs compared to traditional methods. ^{1 2 3 4 5}

What is the purpose of this trial?

This parallel-group randomized controlled trial aims to determine if the location of the lesion(s) in the vestibular system (unilateral versus bilateral, lateral semi-circular canal versus otolith) impacts the effectiveness of adjunct take-home head-mounted display (HMD) virtual reality (VR) therapy in improving patient symptomatology. Fifty patients meeting inclusion criteria will be recruited from the principal investigator's neurotology clinic. Baseline symptomatology questionnaires will be completed, followed by random allocation to virtual reality and control groups. Vestibular rehabilitation and virtual reality protocols will be adhered to for 4 to 8 weeks, followed by symptomatology questionnaires. Data analysis will be conducted to answer the study's objectives.

Research Team

Desmond A Nunez, MD, MBA

Principal Investigator

Division of Otolaryngology, Department of Surgery, The University of British Columbia

Eligibility Criteria

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.

Inclusion Criteria

My diagnosis was confirmed with specific balance tests.

Access to an android or iOS smart phone

I have been diagnosed with a long-term (3+ months) inner ear disorder.

Exclusion Criteria

Pregnant participants

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Remote assessment via phone or Zoom

Baseline Assessment

Baseline data collection including symptomatology questionnaires and patient interviews

2 weeks

Remote assessment via phone or Zoom

Treatment

Participants undergo 4 to 8 weeks of vestibular rehabilitation with weekly in-person sessions and daily at-home exercises. The VR group also uses a VR headset for 20 minutes daily.

4 to 8 weeks

Weekly in-person sessions, daily at-home exercises

Follow-up

Participants are monitored for changes in symptomatology and return VR headsets

2 weeks

Remote assessment and return of equipment

Treatment Details

Interventions

• Standard Vestibular Rehabilitation with Adjunct At Home Virtual Reality Vestibular Rehabilitation
• Standard Vestibular Rehabilitation with Adjunct Auditory Intervention

Trial Overview 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.

Participant Groups

Group I: Virtual Reality Group Experimental Treatment 1 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 Group Active Control 1 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.

Standard Vestibular Rehabilitation with Adjunct At Home Virtual Reality Vestibular Rehabilitation is already approved in United States, European Union for the following indications:

Approved in United States as Virtual Reality Vestibular Rehabilitation for:

• Vestibular disorders
• Balance problems
• Dizziness

Approved in European Union as VR Vestibular Therapy for:

• Vestibular rehabilitation
• Inner ear disorders
• Visual dependence

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

Virtual reality-assisted therapy (VRAT) significantly improves vestibular symptoms in patients with peripheral vestibular disorders compared to conventional vestibular physical therapy (CVPT), as shown by various measures including the Dizziness Handicap Inventory (DHI).

While VRAT shows promise for enhancing rehabilitation outcomes, particularly for peripheral disorders, the high variability in study results indicates a need for further research with larger sample sizes to better understand its effectiveness across different vestibular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Virtual Reality-Assisted Therapy Offer Additional Benefits to Patients With Vestibular Disorders Compared With Conventional Vestibular Physical Therapy? A Meta-analysis. Chu, HY., Song, N., Zhou, ZR., et al.[2023]

A randomized controlled trial involving 322 participants aged 50 and older showed that internet-based vestibular rehabilitation (VR) maintained improvement in vestibular symptoms for up to 36 months, demonstrating its long-term efficacy.

While there were no significant differences in symptom reduction between the VR groups and usual care, a substantial portion of the usual care group (38%) opted to switch to VR after 6 months, indicating a preference for the VR approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online vestibular rehabilitation for chronic vestibular syndrome: 36-month follow-up of a randomised controlled trial in general practice. van Vugt, VA., Ngo, HT., van der Wouden, JC., et al.[2023]

In a study of 20 patients with unilateral vestibular hypofunction, virtual reality (VR) vestibular rehabilitation was evaluated and compared to conventional therapy, showing promising results in improving symptoms of vertigo.

Both VR and conventional therapy groups reported significant improvements in their symptoms, indicating that VR may be an effective alternative for vestibular rehabilitation, although specific statistical outcomes were not detailed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. Stankiewicz, T., Gujski, M., Niedzielski, A., et al.[2021]

In a study of 74 participants with chronic dizziness, those who received expert physiotherapist guidance in a home-based vestibular rehabilitation therapy (VRT) program showed significantly greater improvement in their dizziness scores compared to those who exercised without specific instructions.

Both groups improved over the 8-week study, but the intervention group experienced a more substantial reduction in their Dizziness Handicap Inventory scores, highlighting the importance of tailored instructions for maximizing the effectiveness of home exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific and individualized instructions improve the efficacy of booklet-based vestibular rehabilitation at home - a randomized controlled trial (RCT). Kellerer, S., Amberger, T., Schlick, C., et al.[2023]

A 4-week virtual reality-based vestibular rehabilitation therapy (VRT) program significantly improved dizziness and balance in 25 patients with peripheral vestibular hypofunction, as shown by a reduction in Dizziness Handicap Inventory scores from 54.60 to 16.84 (p < 0.001).

The therapy also enhanced sensory organization and stability, with significant improvements in the Sensory Organization Test scores and movement parameters, indicating that VR-based VRT can effectively enhance posture stability and quality of life for patients with PVH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based vestibular rehabilitation in patients with peripheral vestibular hypofunction. Başoğlu, Y., Şerbetçioğlu, MB., Çelik, İ., et al.[2023]

The study identified two virtual reality games, VR Tunnel Race (VRTR) and VR Real World Bike Racing (VRWBR), as the most effective options for enhancing vestibular rehabilitation therapy, based on assessments from 40 physiotherapists.

VRTR was found to replicate habituation exercises significantly better than another game, while VRWBR was noted for its ease of use and flexibility in adjusting optokinetic stimulation, suggesting it may be the preferred choice for therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation potential of commercially available virtual reality video games. Heffernan, A., Booth, L., Fletcher, R., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Can Virtual Reality-Assisted Therapy Offer Additional Benefits to Patients With Vestibular Disorders Compared With Conventional Vestibular Physical Therapy? A Meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Online vestibular rehabilitation for chronic vestibular syndrome: 36-month follow-up of a randomised controlled trial in general practice. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Specific and individualized instructions improve the efficacy of booklet-based vestibular rehabilitation at home - a randomized controlled trial (RCT). [2023]

5. Turkey pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality-based vestibular rehabilitation in patients with peripheral vestibular hypofunction. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation potential of commercially available virtual reality video games. [2023]