NCT07451093

Brief Summary

The goal of this interventional study is to determine if the use of virtual reality headsets results in an increased risk of seizure in adolescent and adult individuals with epilepsy. The main question it aims to answer are: \- does use of virtual reality headsets with hand controllers result in a higher risk of seizure compared to use of virtual reality headsets without hand controllers Participants will be asked to wear a virtual reality headset during continuous video EEG recording and EEG with be evaluated during three phases: with display turned off, with display turned on without hand controllers, and with display turned on with hand controllers.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

February 12, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

February 12, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

EpilepsySeizureVirtual RealityVRReflex epilepsy

Outcome Measures

Primary Outcomes (1)

  • Change in prevalence of interictal epileptiform discharges

    Interictal epileptiform discharges are counted by two epilepsy trained neurologists. Number of discharges seen are compared between each intervention.

    Three sessions, 15 minutes each

Other Outcomes (1)

  • Seizure

    3 trials, 15 minutes each

Study Arms (1)

Virtual Reality Arm

EXPERIMENTAL

Participants wear VR headset during video EEG recording for a total of 3 sessions, each lasting 15 minutes each.

Other: Virtual Reality Headset, display offOther: Virtual Reality Headset, Display onlyOther: Virtual Reality Headset, Display and Hand Control

Interventions

15 minutes of EEG recording with VR headset worn, display turned off. This will act as a baseline for intervention 2 and 3

Virtual Reality Arm

15 minutes of EEG recording with VR headset worn, display turned on without access to hand controls.

Virtual Reality Arm

15 minutes of EEG recording with VR headset worn, display turned on with access to hand controls

Virtual Reality Arm

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with known or suspected diagnosis of epilepsy with interictal epileptiform discharges seen during current or prior EEG recording
  • Age greater than or equal to 13 years

You may not qualify if:

  • Age less than 13 years (infants, children)
  • Pregnancy
  • Incarceration
  • Moderate-severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

EpilepsySeizuresEpilepsy, Reflex

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jared E Quast, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2026

First Posted

March 5, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations