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Not yet recruiting NCT07451093

Epileptiform Potential of Fully Immersive Virtual Reality

No phase Interventional Epilepsy Seizure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Headset, display off, Virtual Reality Headset, Display only, Virtual Reality Headset, Display and Hand Control.
Who it may be relevant to
Registry conditions: Epilepsy, Seizure. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Virtual Reality Headset, display off
    15 minutes of EEG recording with VR headset worn, display turned off. This will act as a baseline for intervention 2 and 3
  • Other Virtual Reality Headset, Display only
    15 minutes of EEG recording with VR headset worn, display turned on without access to hand controls.
  • Other Virtual Reality Headset, Display and Hand Control
    15 minutes of EEG recording with VR headset worn, display turned on with access to hand controls

Primary outcome measures

  • Change in prevalence of interictal epileptiform discharges [Time frame: Three sessions, 15 minutes each]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Dartmouth Hitchcock Medical Center — Lebanon

Identifiers

NCT: NCT07451093 · 02002874

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗