Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2026-02-21 @ 6:00 AM
Study NCT ID:
NCT02918994
Status:
UNKNOWN
Last Update Posted:
2021-07-27
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LearningRx Cognitive Training for TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2016-09-27', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of overall cognitive function improvement', 'timeFrame': 'within 14 days after completing the intervention', 'description': 'Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities'}], 'secondaryOutcomes': [{'measure': 'Evidence of change in brain activity', 'timeFrame': 'within 30 days after completing the intervention', 'description': 'As confirmed by pretest to post-test changes in electrical activity measured by qEEG'}, {'measure': 'Evidence of reduction in TBI symptoms', 'timeFrame': 'within 14 days after completing the intervention', 'description': 'As confirmed by pretest to post-test changes on the Traumatic Brain Injury Checklist'}, {'measure': 'Evidence of change in brain structure', 'timeFrame': 'within 30 days after completing the intervention', 'description': 'Confirmed by change in pretest to post-test neuroimaging using MRI'}, {'measure': 'Evidence of improvement in visual attention', 'timeFrame': 'with 14 days after completing the intervention', 'description': 'Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)'}, {'measure': 'Evidence of improvement in auditory attention', 'timeFrame': 'with 14 days after completing the intervention', 'description': 'Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury (TBI)']}, 'referencesModule': {'references': [{'pmid': '32670040', 'type': 'DERIVED', 'citation': 'Moore AL, Carpenter DM 2nd, James RL, Miller TM, Moore JJ, Disbrow EA, Ledbetter CR. Neuroimaging and Neuropsychological Outcomes Following Clinician-Delivered Cognitive Training for Six Patients With Mild Brain Injury: A Multiple Case Study. Front Hum Neurosci. 2020 Jun 24;14:229. doi: 10.3389/fnhum.2020.00229. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with Traumatic Brain Injury (TBI).', 'detailedDescription': 'Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for TBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ previously diagnosed with TBI\n* Living in the greater Colorado Springs area\n\nExclusion Criteria:\n\n* No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging'}, 'identificationModule': {'nctId': 'NCT02918994', 'briefTitle': 'LearningRx Cognitive Training for TBI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gibson Institute of Cognitive Research'}, 'officialTitle': 'LearningRx Cognitive Training for Traumatic Brain Injury (TBI): A Multiple Baseline Study Across Cases', 'orgStudyIdInfo': {'id': 'GICR-0916-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LearningRx cognitive training', 'description': 'The intervention is a 60-hour, clinician-delivered cognitive training program.', 'interventionNames': ['Behavioral: LearningRx cognitive training']}], 'interventions': [{'name': 'LearningRx cognitive training', 'type': 'BEHAVIORAL', 'description': 'A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.', 'armGroupLabels': ['LearningRx cognitive training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80919', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Gibson Institute of Cognitive Research', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}], 'overallOfficials': [{'name': 'Christina Ledbetter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gibson Institute of Cognitive Research'}, {'name': 'Amy L Moore, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gibson Institute of Cognitive Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Will add to Harvard Dataverse'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gibson Institute of Cognitive Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}