Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT02408666
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG@HOME (Phase 1 of the Project)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-03-31', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'User wishes and expectations (questionnaire)', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.\n\nIn Phase 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, EEG registrations, daily life, ... . In addition EEG-technologists and neurologists will be interviewed about their experience with EEG registrations and what features their dream EEG-cap would have. The purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.\n\nMinimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50 EEG-technologists or neurologists will be interviewed.\n\nThe results of the interviews will be analysed by the design company pilipili nv.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epilepsy patient or EEG-technologist or neurologist\n\nExclusion Criteria:\n\n* No experience with EEG'}, 'identificationModule': {'nctId': 'NCT02408666', 'briefTitle': 'EEG@HOME (Phase 1 of the Project)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'orgStudyIdInfo': {'id': 'EC/2014/0319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interview', 'description': 'Interview of epilepsy patients and their family about their experience with epilepsy, EEG registrations and daily life.\n\nInterview of EEG-technologists and neurologists about their experience with EEG registrations and expections when thinking of a ideal EEG-cap.', 'interventionNames': ['Other: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'armGroupLabels': ['Interview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pilipili NV', 'class': 'INDUSTRY'}, {'name': 'Imec', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. Kristl Vonck', 'investigatorFullName': 'Neurologie', 'investigatorAffiliation': 'University Hospital, Ghent'}}}}