Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:55 AM
Study NCT ID:
NCT07451093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epileptiform Potential of Fully Immersive Virtual Reality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D020195', 'term': 'Epilepsy, Reflex'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Seizure', 'timeFrame': '3 trials, 15 minutes each', 'description': 'Detection of a clinical or electrographic seizure event occurring with any intervention'}], 'primaryOutcomes': [{'measure': 'Change in prevalence of interictal epileptiform discharges', 'timeFrame': 'Three sessions, 15 minutes each', 'description': 'Interictal epileptiform discharges are counted by two epilepsy trained neurologists. Number of discharges seen are compared between each intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Seizure', 'Virtual Reality', 'VR', 'Reflex epilepsy'], 'conditions': ['Epilepsy', 'Seizure']}, 'descriptionModule': {'briefSummary': '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:\n\n\\- 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects with known or suspected diagnosis of epilepsy with interictal epileptiform discharges seen during current or prior EEG recording\n* Age greater than or equal to 13 years\n\nExclusion Criteria:\n\n* Age less than 13 years (infants, children)\n* Pregnancy\n* Incarceration\n* Moderate-severe cognitive impairment'}, 'identificationModule': {'nctId': 'NCT07451093', 'briefTitle': 'Epileptiform Potential of Fully Immersive Virtual Reality', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Epileptiform Potential of Fully Immersive Virtual Reality', 'orgStudyIdInfo': {'id': '02002874'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Arm', 'description': 'Participants wear VR headset during video EEG recording for a total of 3 sessions, each lasting 15 minutes each.', 'interventionNames': ['Other: Virtual Reality Headset, display off', 'Other: Virtual Reality Headset, Display only', 'Other: Virtual Reality Headset, Display and Hand Control']}], 'interventions': [{'name': 'Virtual Reality Headset, display off', 'type': 'OTHER', 'description': '15 minutes of EEG recording with VR headset worn, display turned off. This will act as a baseline for intervention 2 and 3', 'armGroupLabels': ['Virtual Reality Arm']}, {'name': 'Virtual Reality Headset, Display only', 'type': 'OTHER', 'description': '15 minutes of EEG recording with VR headset worn, display turned on without access to hand controls.', 'armGroupLabels': ['Virtual Reality Arm']}, {'name': 'Virtual Reality Headset, Display and Hand Control', 'type': 'OTHER', 'description': '15 minutes of EEG recording with VR headset worn, display turned on with access to hand controls', 'armGroupLabels': ['Virtual Reality Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'contacts': [{'name': 'Jared E Quast, MD', 'role': 'CONTACT', 'email': 'jared.e.quast@hitchcock.org', 'phone': '6033505104'}, {'name': 'Jared E Quast, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'centralContacts': [{'name': 'Jared E Quast, MD', 'role': 'CONTACT', 'email': 'jared.e.quast@hitchcock.org', 'phone': '6033505104'}], 'overallOfficials': [{'name': 'Jared E Quast, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jared.E.Quast', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}