- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451093
Epileptiform Potential of Fully Immersive Virtual Reality
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jared E Quast, MD
- Phone Number: 6033505104
- Email: jared.e.quast@hitchcock.org
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
-
Contact:
- Jared E Quast, MD
- Phone Number: 6033505104
- Email: jared.e.quast@hitchcock.org
-
Principal Investigator:
- Jared E Quast, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Arm
Participants wear VR headset during video EEG recording for a total of 3 sessions, each lasting 15 minutes each.
|
15 minutes of EEG recording with VR headset worn, display turned off.
This will act as a baseline for intervention 2 and 3
15 minutes of EEG recording with VR headset worn, display turned on without access to hand controls.
15 minutes of EEG recording with VR headset worn, display turned on with access to hand controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in prevalence of interictal epileptiform discharges
Time Frame: Three sessions, 15 minutes each
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Seizure
Time Frame: 3 trials, 15 minutes each
|
Detection of a clinical or electrographic seizure event occurring with any intervention
|
3 trials, 15 minutes each
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jared E Quast, MD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02002874
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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