NCT05296057: AnxEpiVR

Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety

Completed NA Last updated 23 October 2023

What this trial tests

NA trial testing Participants Receiving VR-Exposure Therapy Treatment in Epilepsy in 5 participants. Completed in 20 September 2023.

Timeline

24 March 2023

Primary endpoint
20 September 2023

20 September 2023

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	24 March 2023
Primary completion	20 September 2023
Estimated completion	20 September 2023
Sites	1 location across Canada

Drugs / interventions tested

• Participants Receiving VR-Exposure Therapy Treatment

Conditions studied

• Epilepsy — all drugs for Epilepsy →
• Anxiety Disorders and Symptoms — all drugs for Anxiety Disorders and Symptoms →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 65, any sex, with Epilepsy or Anxiety Disorders and Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Over 28% of people with epilepsy (PwE) struggle from at least one anxiety disorder, making anxiety the most common psychiatric comorbidity in this population. Despite the importance of treating anxiety in PwE, it has not received much research attention and is often unrecognized and untreated. Research has suggested that including exposure therapy (ET) as a part of an anxiety treatment may be helpful for decreasing anxiety in PwE. Research has also shown that Virtual Reality (VR) is an effective and helpful tool for delivering ET in a number of different types of anxiety disorders, such as posttraumatic stress disorder, panic disorder, and social anxiety disorder.

To the investigators' knowledge, no research has been conducted to-date on using VR to deliver ET (VR-ET) in PwE. People with epilepsy have commonly been excluded from VR studies due to the concern that it may trigger seizures in people with photosensitive epilepsy. Although limited research is available on the use of VR in PwE, hesitations regarding the use of VR in this population have not been substantiated and clinicians and researchers are increasingly considering VR for use in this population.

The use of an immersive VR head-mounted display to deliver ET in this population offers several benefits. For example, studies suggest that VR-ET is an especially useful method for customized treatment when it is not safe or practical to do exposures. This is important to consider as it may not be practical to do exposures in-person during times of pandemic, such as the COVID-19 pandemic. Even outside of the pandemic, VR reduces the need for travel, which is difficult for PwE in normal circumstances as driver's licences are typically suspended after a confirmed seizure. Using VR for ET as opposed to traditional ET can also save money and time, and allow for more equitable access to healthcare resources for those who may not live in urban centers.

The investigators designed and will be rigorously evaluating a VR-ET program administered in private residences specific for PwE that focuses on decreasing anxiety that is specifically related to their epilepsy or seizures. This study would be among the first to evaluate VR-ET in this population. This study will also contribute to the limited body of research that currently exists managing comorbid anxiety in PwE as well as the minimal existing literature about fears specifically related to epilepsy or seizures.

The overall primary objective of this study is to report on the feasibility and appropriateness of the protocol and evaluation instruments for use in the subsequent larger clinical trial. The secondary objective is to evaluate whether VR-ET reduces epilepsy- or seizure-related anxiety in PwE. It is hypothesized that PwE will experience decreased levels of epilepsy-related anxiety after undergoing VR-ET. These findings will be used to inform a future randomized controlled trial.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Describing epilepsy-related anxiety to inform the design of a virtual reality exposure therapy: Results from Phase 1 of the AnxEpiVR clinical trial.
   Tchao D, Lewis-Fung S, Gray H, Pardini S, et al · · 2023 · cited 2× · PMID 36794093 · DOI 10.1016/j.ebr.2023.100588
2. Virtual Reality Therapy for People With Epilepsy and Related Anxiety: Protocol for a 3-Phase Pilot Clinical Trial.
   Gray HG, Tchao D, Lewis-Fung S, Pardini S, et al · · 2023 · cited 2× · PMID 36692939 · DOI 10.2196/41523
3. Feasibility and impact of virtual reality exposure therapy on epilepsy-specific anxiety: Phase 3 of the AnxEpiVR pilot clinical trial.
   Gray HG, Tchao D, Lewis-Fung S, Carman-Gray G, et al · · 2026 · PMID 41658047 · DOI 10.1016/j.ebr.2025.100845