EpilepsyAnxEMUNCT06028945
Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety
A study testing HMD: Virtual Reality Exposure Therapy and HMD: Neutral Game in people with Epilepsy and Anxiety Disorders, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this randomized control trial is to evaluate the impact of Virtual Reality (VR) Exposure Therapy (ET) on people with epilepsy who experience epilepsy/seizure-specific (ES) interictal anxiety. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Anxiety Disorders
- What is being tested?
- HMD: Virtual Reality Exposure Therapy and HMD: Neutral Game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 24 May 2024to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are at least 18 years old
- 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
Who cannot join
- Individuals with an unconfirmed epilepsy diagnosis
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety In People With Epilepsy
The purpose of this randomized control trial is to evaluate the impact of Virtual Reality (VR) Exposure Therapy (ET) on people with epilepsy who experience epilepsy/seizure-specific (ES) interictal anxiety. The main questions it aims to answer are:
- Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this population?
- Are the study procedures sufficiently simple for participants to follow?
Read more
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.
Read the detailed description
BASELINE VISIT #1 (T0):
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
- Epilepsy, Anxiety Disorders
- Being tested
- HMD: Virtual Reality Exposure Therapy, HMD: Neutral Game
- Keywords
- Epilepsy, Anxiety, Virtual Reality, Exposure Therapy, Cognitive Behavioural Therapy, Seizure, Interictal Anxiety
- Medical subject headings
- Epilepsy, Anxiety Disorders, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMD: Virtual Reality Exposure TherapyDevice
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 GameDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: VR-ET | Experimental | 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. Receives: Device: HMD: Virtual Reality Exposure Therapy |
| Group 2: Neutral Game | Active comparator | 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. Receives: Device: HMD: Neutral Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fast Motion Sickness (FMS) Scale
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness during baseline training.
Measured: Baseline (T0)
Epilepsy Anxiety Survey Instrument (EASI)
An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy. Scores can range from 0 to 54, where higher scores indicate more severe anxiety.
Measured: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy. Scores can range from 6 to 24, where higher scores indicate more severe depression.
Measured: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Liebowitz Social Anxiety Scale
A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations. Scores range from 0 to 144, where higher scores indicate more severe social anxiety.
Measured: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
GAD-7
A 7-item scale used to screen for generalized anxiety disorder. Scores range from 0 to 21, where higher scores indicate more severe anxiety.
Measured: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
QOLIE - 31
A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy. Scores range from 0 to 100, where higher scores reflect higher quality of life.
Measured: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Mobility Inventory for Agoraphobia
On this instrument, 26 situations and locations (including shopping malls, public transit, and social gatherings) are rated for avoidance both when accompanied by a trusted companion and when alone. Average scores for each subscale (accompanied vs alone) range from 1 (never avoid) to 5 (always avoid). The instrument also collects information on panic attacks, with a score ranging from 1 (very mild) to 5 (extremely severe).
Measured: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Subjective Units of Distress/Discomfort Scale (SUDS)
A single assessment question where level of anxiety is rated on a visual analog scale ranging from 0 (no distress; totally relaxed) to 100 (highest anxiety/distress that you have ever felt). This scale will be used to measure anxiety immediately before and after VR exposures.
Measured: Intervention Period (T1)
Fast Motion Sickness (FMS) Scale
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness immediately after using VR.
Measured: Intervention Period (T1)
System Usability Scale (SUS)
A 10-item survey that provides a quick assessment of the usability of various products and services, including hardware, software, mobile devices, websites and applications. Scores range from 0 to 100, with higher scores indicating higher level of usability.
Measured: Post-Intervention (T2)
Igroup Presence Questionnaire (IPQ)
Several subscales to measure sense of presence, spatial presence, involvement, and experienced realism while in the virtual environment. Average scores for the different subscales range from 0 to 6, with higher scores indicating higher sense of presence/realism.
Measured: Post-Intervention (T2)
Post-Intervention Interview (approx. 15 min)
The semi-structured exit interview will be conducted by a researcher the day after the participant has completed their final VR session. The purpose of this interview is to collect feedback on the VR-system usability and training, treatment delivery, overall experience, and (experimental arm only) effectiveness of VR exposure scenes. Participants will also be asked about the intervention's perceived change on their anxiety.
Measured: Post-Intervention (T2)
Follow-Up Interview (approx. 15 min)
The follow-up phone interview will take place one month post-intervention. The researcher will call the participant and inquire about their general and ES-interictal anxiety levels, as well as their current levels of, and any perceived changes in, fear/comfort and avoidance of feared scenarios.
Measured: 1-Month Follow-Up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start24 May 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, Randomized, Pilot, Pragmatic, Open label
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Bui, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028945
- Sponsor's protocol ID
- 23-5516
- Acronym
- AnxEMU
- Status last verified
- Dec 2024
- First submitted
- 31 Aug 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31037466Munger 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.
PubMed 24652453Munger 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.
PubMed 36701931Deng 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.
PubMed 31382122Tychsen 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.
PubMed 32104130Gribkoff 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.
PubMed 1382122McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.
PubMed 2300295Gray 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.
PubMed 36692939Tchao 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.
PubMed 36794093
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety In People With Epilepsy
- ClinicalTrials.gov ID
- NCT06028945
- Acronym / sponsor ID
- AnxEMU / 23-5516
- Conditions
- Epilepsy, Anxiety Disorders
- Keywords
- Epilepsy, Anxiety, Virtual Reality, Exposure Therapy, Cognitive Behavioural Therapy, Seizure, Interictal Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized control trial is to evaluate the impact of Virtual Reality (VR) Exposure Therapy (ET) on people with epilepsy who experience epilepsy/seizure-specific (ES) interictal anxiety. The main questions it aims to answer are:
- Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this population?
- 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.
Detailed description
BASELINE VISIT #1 (T0):
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, Randomized, Pilot, Pragmatic, Open label
| Arm | Type | Receives |
|---|---|---|
| Group 1: VR-ET | Experimental | Device: HMD: Virtual Reality Exposure TherapyGroup 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. |
| Group 2: Neutral Game | Active comparator | Device: HMD: Neutral GameGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who are at least 18 years old
- 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
Key exclusion criteria (6 listed)
- Individuals with an unconfirmed epilepsy diagnosis
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMD: Virtual Reality Exposure TherapyThe 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. | Device | Group 1: VR-ET |
| HMD: Neutral GameThe 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. | Device | Group 2: Neutral Game |
Primary outcome
Fast Motion Sickness (FMS) Scale
Time frame: Baseline (T0)
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness during baseline training.
Epilepsy Anxiety Survey Instrument (EASI)
Time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy. Scores can range from 0 to 54, where higher scores indicate more severe anxiety.
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
Time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy. Scores can range from 6 to 24, where higher scores indicate more severe depression.
Liebowitz Social Anxiety Scale
Time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations. Scores range from 0 to 144, where higher scores indicate more severe social anxiety.
GAD-7
Time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 7-item scale used to screen for generalized anxiety disorder. Scores range from 0 to 21, where higher scores indicate more severe anxiety.
QOLIE - 31
Time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy. Scores range from 0 to 100, where higher scores reflect higher quality of life.
Mobility Inventory for Agoraphobia
Time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
On this instrument, 26 situations and locations (including shopping malls, public transit, and social gatherings) are rated for avoidance both when accompanied by a trusted companion and when alone. Average scores for each subscale (accompanied vs alone) range from 1 (never avoid) to 5 (always avoid). The instrument also collects information on panic attacks, with a score ranging from 1 (very mild) to 5 (extremely severe).
Subjective Units of Distress/Discomfort Scale (SUDS)
Time frame: Intervention Period (T1)
A single assessment question where level of anxiety is rated on a visual analog scale ranging from 0 (no distress; totally relaxed) to 100 (highest anxiety/distress that you have ever felt). This scale will be used to measure anxiety immediately before and after VR exposures.
Fast Motion Sickness (FMS) Scale
Time frame: Intervention Period (T1)
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness immediately after using VR.
System Usability Scale (SUS)
Time frame: Post-Intervention (T2)
A 10-item survey that provides a quick assessment of the usability of various products and services, including hardware, software, mobile devices, websites and applications. Scores range from 0 to 100, with higher scores indicating higher level of usability.
Igroup Presence Questionnaire (IPQ)
Time frame: Post-Intervention (T2)
Several subscales to measure sense of presence, spatial presence, involvement, and experienced realism while in the virtual environment. Average scores for the different subscales range from 0 to 6, with higher scores indicating higher sense of presence/realism.
Post-Intervention Interview (approx. 15 min)
Time frame: Post-Intervention (T2)
The semi-structured exit interview will be conducted by a researcher the day after the participant has completed their final VR session. The purpose of this interview is to collect feedback on the VR-system usability and training, treatment delivery, overall experience, and (experimental arm only) effectiveness of VR exposure scenes. Participants will also be asked about the intervention's perceived change on their anxiety.
Follow-Up Interview (approx. 15 min)
Time frame: 1-Month Follow-Up (T3)
The follow-up phone interview will take place one month post-intervention. The researcher will call the participant and inquire about their general and ES-interictal anxiety levels, as well as their current levels of, and any perceived changes in, fear/comfort and avoidance of feared scenarios.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 31037466Hingray 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.
- Results publication: PubMed 24652453Munger 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.
- Results publication: PubMed 36701931Munger 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.
- Results publication: PubMed 31382122Deng 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.
- Results publication: PubMed 32104130Tychsen 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.
- Results publication: PubMed 1382122Gribkoff 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.
- Results publication: PubMed 2300295McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.
- Results publication: PubMed 36692939Gray 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.
- Results publication: PubMed 36794093Tchao 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.
- EASI-18Link provided by the sponsor.
- Liebowitz Social Anxiety ScaleLink provided by the sponsor.
- Mobility Inventory for AgoraphobiaLink provided by the sponsor.
- Subjective Units of Distress/Discomfort Scale (SUDS)Link provided by the sponsor.
- System Usability Scale (SUS)Link provided by the sponsor.
- Igroup Presence Questionnaire (IPQ)Link provided by the sponsor.
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Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Bui principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMD: Virtual Reality Exposure Therapy and HMD: Neutral Game in people with Epilepsy and Anxiety Disorders, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fast Motion Sickness (FMS) Scale (time frame: Baseline (T0)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06028945, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.