Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety
NCT ID: NCT06028945
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
14 participants
INTERVENTIONAL
2024-05-24
2024-11-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this population?
2. Are the study procedures sufficiently simple for participants to follow?
Study Design Summary:
* Fourteen (14) participants will be randomized into either an Experimental arm (receiving VR-ET) or Control arm
* Participants will be expected to have VR-ET twice a day (5 min/session) for up to 10 days
* Participants will complete self-reported questionnaires about anxiety, depression, quality life, and avoidance behaviours at baseline (T0), after completing their VR program (T2), and at a one-month follow-up (T3).
* Participants will have a short interview with a researcher after completing their VR program (T2) as well as at a one-month follow-up (T3).
Researchers will attempt to answer the study questions based on outcome measures taken at various timepoints and qualitative feedback from interviews.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety
NCT05296057
Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study
NCT03446664
Vagus Nerve Stimulation Titration Protocol to Improve Tolerance and Accelerate Adaptation
NCT02385526
Assessing Comorbidities in Epilepsy Using Eye Movement Recordings
NCT06310772
EMR Outcomes: Anxiety and Depression in Epilepsy
NCT03879525
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The first study visit will take place at the participant's bedside in the EMU with a member of the research team. The participant will be asked to complete several questionnaires including: demographic/health history, anxiety, depression, avoidance behaviours, and quality of life. The researcher will show the participant a short neutral video with the VR device and check for symptoms of motion sickness that might occur using a scale from 0 to 20. Next the participant will work with the researcher to identify the most appropriate exposure therapy scenario. Finally the participant will be randomized into either Group 1 (Experimental Group) or Group 2 (Control Group) and receive training on the VR system specific to their group assignment.
INTERVENTION (T1):
Participants will be encouraged to use the VR system throughout their EMU stay, twice per day for up to 10 days. Each session will involve using VR for approximately 5 minutes. The intervention may last fewer than 10 days if any participant is discharged early from the EMU, or (for Group 1 participants) all levels of the exposure therapy is completed in less than 10 days. Before and after each exposure, participants will be asked to rate their anxiety level on a scale from 0 to 100. After each exposure, participants will also be asked to rate any motion sickness that might result from using VR on a scale from 0 to 20.
POST-INTERVENTION VISIT #2 (T2)
The second study visit will take place after the participant's last VR session. Participants will be asked to repeat questionnaires from Visit #1 on anxiety, depression, avoidance behaviours, and quality of life. Participants will also complete questionnaires about sense of presence in VR and usability of the system. Finally participants will have a short interview with the researcher to discuss their experience using VR and any thoughts about whether the intervention had an impact on their anxiety.
1-MONTH FOLLOW-UP VISIT #3 (T3)
The third study visit will take place one (1) month after Visit #2. A researcher will follow-up with a phone interview and provide a link through email for participants to repeat baseline questionnaires about anxiety, depression, avoidance behaviours, and quality of life. However if participants prefer, they may request the researcher to record their responses to the questionnaires over the phone rather than completing the web-based questionnaires.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: VR-ET
Group 1 will receive the VR-ET for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.
HMD: Virtual Reality Exposure Therapy
The virtual reality exposure therapy uses 360-degree videos delivered through a head mounted display (HMD). Participants will be matched with one of three available exposure hierarchies: Social Party Scenario, Subway Scenario, or Shopping Mall Scenario. Each hierarchy comprises seven 5-min scenes ordered in increasing intensity (from low to high anxiety). Participants are gradually exposed to scenes, viewed twice per day for up to 10 days, while rating their anxiety immediately before and after the exposures. Anxiety ratings will inform when participants may advance to the next level intensity in the exposure hierarchy.
Group 2: Neutral Game
Group 2 will have access to a VR device with a "neutral" game for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.
HMD: Neutral Game
The neutral game is a virtual-reality based game that is not designed to provoke anxiety. Participants assigned to the neutral game will play for 5 minutes twice per day for up to 10 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HMD: Virtual Reality Exposure Therapy
The virtual reality exposure therapy uses 360-degree videos delivered through a head mounted display (HMD). Participants will be matched with one of three available exposure hierarchies: Social Party Scenario, Subway Scenario, or Shopping Mall Scenario. Each hierarchy comprises seven 5-min scenes ordered in increasing intensity (from low to high anxiety). Participants are gradually exposed to scenes, viewed twice per day for up to 10 days, while rating their anxiety immediately before and after the exposures. Anxiety ratings will inform when participants may advance to the next level intensity in the exposure hierarchy.
HMD: Neutral Game
The neutral game is a virtual-reality based game that is not designed to provoke anxiety. Participants assigned to the neutral game will play for 5 minutes twice per day for up to 10 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Individuals admitted to the EMU
* Individuals who have self-reported anxiety related to having epilepsy or seizures
* Individuals who score \<15 on the Fast Motion Sickness (FMS) after the VR neutral demo
Exclusion Criteria
* Individuals with stereotaxic EEG monitoring
* Individuals with photosensitive epilepsy
* Individuals with open wounds on the face or cervical conditions or injuries that would make it unsafe for use the VR headset
* Individuals who have started an antidepressant, antianxiety drug, or medical marijuana in the last twelve weeks
* Individuals who cannot speak or understand English
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Health Network, Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Esther Bui
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Munger Clary HM, Giambarberi L, Floyd WN, Hamberger MJ. Afraid to go out: Poor quality of life with phobic anxiety in a large cross-sectional adult epilepsy center sample. Epilepsy Res. 2023 Feb;190:107092. doi: 10.1016/j.eplepsyres.2023.107092. Epub 2023 Jan 16.
Munger Clary HM. Anxiety and epilepsy: what neurologists and epileptologists should know. Curr Neurol Neurosci Rep. 2014 May;14(5):445. doi: 10.1007/s11910-014-0445-9.
Hingray C, McGonigal A, Kotwas I, Micoulaud-Franchi JA. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep. 2019 Apr 29;21(6):40. doi: 10.1007/s11920-019-1029-9.
Deng W, Hu D, Xu S, Liu X, Zhao J, Chen Q, Liu J, Zhang Z, Jiang W, Ma L, Hong X, Cheng S, Liu B, Li X. The efficacy of virtual reality exposure therapy for PTSD symptoms: A systematic review and meta-analysis. J Affect Disord. 2019 Oct 1;257:698-709. doi: 10.1016/j.jad.2019.07.086. Epub 2019 Jul 30.
Tychsen L, Thio LL. Concern of Photosensitive Seizures Evoked by 3D Video Displays or Virtual Reality Headsets in Children: Current Perspective. Eye Brain. 2020 Feb 11;12:45-48. doi: 10.2147/EB.S233195. eCollection 2020.
Gribkoff VK, Lum-Ragan JT. Evidence for nitric oxide synthase inhibitor-sensitive and insensitive hippocampal synaptic potentiation. J Neurophysiol. 1992 Aug;68(2):639-42. doi: 10.1152/jn.1992.68.2.639.
McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.
Gray HG, Tchao D, Lewis-Fung S, Pardini S, Harris LR, Appel L. Virtual Reality Therapy for People With Epilepsy and Related Anxiety: Protocol for a 3-Phase Pilot Clinical Trial. JMIR Res Protoc. 2023 Jan 24;12:e41523. doi: 10.2196/41523.
Tchao D, Lewis-Fung S, Gray H, Pardini S, Harris LR, Appel L. Describing epilepsy-related anxiety to inform the design of a virtual reality exposure therapy: Results from Phase 1 of the AnxEpiVR clinical trial. Epilepsy Behav Rep. 2023 Jan 16;21:100588. doi: 10.1016/j.ebr.2023.100588. eCollection 2023.
Related Links
Access external resources that provide additional context or updates about the study.
Liebowitz Social Anxiety Scale
Mobility Inventory for Agoraphobia
Subjective Units of Distress/Discomfort Scale (SUDS)
System Usability Scale (SUS)
Igroup Presence Questionnaire (IPQ)
Fast Motion Sickness Scale (FMS)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-5516
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.