Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-03-09 @ 8:12 AM
Study NCT ID:
NCT02399293
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2015-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer-based Attention Training in Patients With Acquired Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-20', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline Raven's advanced progressive matrices at the end of training", 'timeFrame': 'within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline WAIS-III Working Memory Index at the end of training', 'timeFrame': 'within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.'}, {'measure': 'Change from baseline WAIS-III Processing Speed Index at the end of training', 'timeFrame': 'within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.'}, {'measure': 'Change from baseline Operation Span at the end of training', 'timeFrame': 'within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.'}, {'measure': 'Change from baseline Stroop color-text interference at the end of training', 'timeFrame': 'within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.'}, {'measure': 'Change from baseline AMPS at the end of training', 'timeFrame': 'within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive training', 'Cognitive rehabilitation', 'Acquired brain injury', 'N-back', 'Visual Search', 'Cognitive transfer'], 'conditions': ['Brain Injuries']}, 'descriptionModule': {'briefSummary': 'Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with acquired brain injury and non-impaired subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* subjects should be able to do both task at level at the time of recruitment\n* Informed consent\n* (for brain injured patients) training must not interfere with treatment as usual.\n* (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.'}, 'identificationModule': {'nctId': 'NCT02399293', 'briefTitle': 'Computer-based Attention Training in Patients With Acquired Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Computer-based Attention Training in Patients With Acquired Brain Injury', 'orgStudyIdInfo': {'id': 'hnrc_nback'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient N-back', 'description': 'Patients training the N-back task', 'interventionNames': ['Behavioral: N-back']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient Visual Search', 'description': 'Patients training the Visual-Search task', 'interventionNames': ['Behavioral: Visual Search']}, {'type': 'EXPERIMENTAL', 'label': 'Non-impaired N-back', 'description': 'Non-impaired training the N-back task', 'interventionNames': ['Behavioral: N-back']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-impaired Visual Search', 'description': 'Non-impaired training the Visual-Search task', 'interventionNames': ['Behavioral: Visual Search']}], 'interventions': [{'name': 'N-back', 'type': 'BEHAVIORAL', 'description': 'The N-back task required patients to monitor a continuous sequence of stimuli (in this experiment audio and visual stimuli). Press a button if the current stimulus is the same as that shown N back in the sequence. N increases if performance is good and decreases if performance is poor.\n\nSubjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.', 'armGroupLabels': ['Non-impaired N-back', 'Patient N-back']}, {'name': 'Visual Search', 'type': 'BEHAVIORAL', 'description': 'The Visual Search task consists of a NxN array of shapes. Press the button if a certain target stimulus is present in this array. N increases if performance is good and decreases if performance is poor.\n\nSubjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.', 'armGroupLabels': ['Non-impaired Visual Search', 'Patient Visual Search']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jonas Lindeløv, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hammel Neurocenter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regionshospitalet Hammel Neurocenter', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.sc.', 'investigatorFullName': 'Jonas Lindeløv', 'investigatorAffiliation': 'Aalborg University'}}}}