Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT00860951
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2009-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
P300 Brain Computer Interface Keyboard to Operate Assistive Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'janeh@umich.edu', 'phone': '734-936-7177', 'title': 'Jane Huggins', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Brain Computer Interface Keyboard', 'description': 'What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?\n\nBrain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Typing With BCI Keyboard.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BCI Environment', 'description': 'Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.'}, {'id': 'OG001', 'title': 'Computer Environment', 'description': 'Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.'}, {'id': 'OG002', 'title': 'Assistive Technology Enironment', 'description': 'Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '100'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '100'}, {'value': '83', 'groupId': 'OG002', 'lowerLimit': '36', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'mean score from 3 sessions over 29 days', 'description': 'Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.\n\nOnce sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.', 'unitOfMeasure': 'percentage accuracy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brain Computer Interface Keyboard', 'description': 'What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?\n\nBrain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brain Computer Interface Keyboard', 'description': 'What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?\n\nBrain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the protocol.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2009-03-11', 'resultsFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-27', 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Typing With BCI Keyboard.', 'timeFrame': 'mean score from 3 sessions over 29 days', 'description': 'Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.\n\nOnce sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Normal'], 'conditions': ['Healthy', 'Amyotrophic Lateral Sclerosis', 'Neuromuscular Disease', 'Spinal Cord Injury', 'Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to develop tools enable people who are paralyzed to operate technology and access computers. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology.', 'detailedDescription': 'The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain computer interfaces (BCIs). BCIs would let a person use brain signals to operate technology. The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a keyboard to let people operate these technologies without moving. However, the investigators need people to test the BCI so that the investigators can see how well it can replace a keyboard. The investigators want to understand how well it can work so that the investigators can make it useful for people who are paralyzed. The investigators will ask people to use the BCI to do things like make a communication system speak or type words on a computer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older.\n* Able to read text on a computer screen\n* Able to understand and remember instructions concerning participation\n\nExclusion Criteria:\n\n* Unable give informed consent.\n* Unable to understand and follow instructions.\n* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.\n* Known to have photosensitive epilepsy.\n* Open head lesions or sores'}, 'identificationModule': {'nctId': 'NCT00860951', 'briefTitle': 'P300 Brain Computer Interface Keyboard to Operate Assistive Technology', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'orgStudyIdInfo': {'id': 'H0002 - AT P300 Keyboard Study'}, 'secondaryIdInfos': [{'id': '5R21HD054697', 'link': 'https://reporter.nih.gov/quickSearch/5R21HD054697', 'type': 'NIH'}, {'id': 'H133G090005', 'type': 'OTHER_GRANT', 'domain': 'Department of Education'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Brain Computer Interface Keyboard', 'description': 'What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?', 'interventionNames': ['Device: Brain Computer Interface Keyboard']}], 'interventions': [{'name': 'Brain Computer Interface Keyboard', 'type': 'DEVICE', 'description': 'Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.', 'armGroupLabels': ['Brain Computer Interface Keyboard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Direct Brain Interface Project', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '12201', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Wadsworth Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Jane Huggins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Jane Huggins, PhD', 'investigatorAffiliation': 'University of Michigan'}}}}