Health TrialsbyHealthPanel

Epileptiform Potential of Fully Immersive Virtual Reality

ConditionsEpilepsySeizure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age less than 13 years (infants, children)

Pregnancy

Incarceration

Moderate-severe cognitive impairment

Trial design

Design model

Single group

Treatments tested in this trial

  • Virtual Reality Headset, display off

    Other intervention

    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 Headset, Display only

    Other intervention

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

  • Virtual Reality Headset, Display and Hand Control

    Other intervention

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Virtual Reality ArmExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
Three sessions, 15 minutes each

Secondary outcomes

Other outcomes

1

Seizure

Detection of a clinical or electrographic seizure event occurring with any intervention

Time frame
3 trials, 15 minutes each

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: