Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety

NCT06028945 | Completed

• 1 other identifier: 23-5516
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Epilepsy; Anxiety Disorders

Keywords

Epilepsy; Anxiety; Virtual Reality; Exposure Therapy; Cognitive Behavioural Therapy; Seizure; Interictal Anxiety

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  1-Month Follow-Up (T3)

Study Arms (2)

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.

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.

Device: HMD: Neutral Game

Interventions

HMD: Virtual Reality Exposure Therapy DEVICE

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 1: VR-ET

HMD: Neutral Game DEVICE

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.

Group 2: Neutral Game

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (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.

  PMID: 31037466 RESULT

• 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.

  PMID: 24652453 RESULT

• 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.

  PMID: 36701931 RESULT

• 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.

  PMID: 31382122 RESULT

• 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.

  PMID: 32104130 RESULT

• 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.

  PMID: 1382122 RESULT

• McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.

  PMID: 2300295 RESULT

• 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.

  PMID: 36692939 RESULT

• 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.

  PMID: 36794093 RESULT

Related Links

• EASI-18
• 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)
• GAD-7

MeSH Terms

Conditions

Epilepsy; Anxiety Disorders; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esther Bui

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, Randomized, Pilot, Pragmatic, Open label

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: May 24, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: November 17, 2025

Record last verified: 2024-12

Locations

CA (1)