Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT02747394
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Training for Fragile X Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005600', 'term': 'Fragile X Syndrome'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-01', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory', 'timeFrame': '5-6 weeks', 'description': 'Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory'}], 'secondaryOutcomes': [{'measure': 'Wechsler Intelligence Scale for Children-IV Digit Span', 'timeFrame': '5-6 weeks'}, {'measure': 'Wechsler Intelligence Scale for Children-IV Digit Span', 'timeFrame': '3 month followup'}, {'measure': 'Kiddie Test of Attentional Performance (KiTAP)', 'timeFrame': '5-6 weeks'}, {'measure': 'Kiddie Test of Attentional Performance (KiTAP)', 'timeFrame': '3 month followup'}, {'measure': 'Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)', 'timeFrame': '5-6 weeks'}, {'measure': 'Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)', 'timeFrame': '3 month followup'}, {'measure': 'Swanson, Nolan and Pelham (SNAP-IV)', 'timeFrame': '5-6 weeks'}, {'measure': 'Swanson, Nolan and Pelham (SNAP-IV)', 'timeFrame': '3 month followup'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fragile X Syndrome']}, 'referencesModule': {'references': [{'pmid': '30982467', 'type': 'DERIVED', 'citation': 'Hessl D, Schweitzer JB, Nguyen DV, McLennan YA, Johnston C, Shickman R, Chen Y. Cognitive training for children and adolescents with fragile X syndrome: a randomized controlled trial of Cogmed. J Neurodev Disord. 2019 Apr 15;11(1):4. doi: 10.1186/s11689-019-9264-2.'}]}, 'descriptionModule': {'briefSummary': 'Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits that interfere with learning, socialization and emotion regulation. Extensive research focused on the animal models of FXS show that targeted pharmacological agents can normalize synaptic connectivity and reverse cognitive and behavioral deficits. This translational work has led to multiple national and international controlled trials in humans with FXS now underway. However, in contrast to the heavy focus on medication treatments, there have been no controlled trials to empirically-validate cognitive or behavioral interventions for FXS. The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the efficacy of Cogmed, a cognitive training program proven to enhance working memory and executive/frontal function in a variety of clinical populations. Demonstration of effective Cogmed training for FXS would represent a major advance in the field, one that may also generalize to other forms of intellectual disability. Furthermore, it is critical to determine whether the targeted pharmacological treatments can accelerate learning and cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for testing hypotheses focused on combined efficacy of medication and cognitive training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fragile X full mutation\n* normal or corrected vision\n* English or Spanish speaking\n* ability to pass three-span items following completion of a Cogmed training session at baseline\n* parental agreement to maintain adherence to the training schedule and to not alter other treatments during the study unless medically necessary\n\nExclusion Criteria:\n\n* previous Cogmed training\n* significant medical problems that would interfere with the study or significant brain trauma'}, 'identificationModule': {'nctId': 'NCT02747394', 'briefTitle': 'Cognitive Training for Fragile X Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Cognitive Training for Fragile X Syndrome', 'orgStudyIdInfo': {'id': '428005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adaptive Cogmed', 'description': '5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed', 'interventionNames': ['Other: Working Memory Training']}, {'type': 'OTHER', 'label': 'Non-Adaptive Cogmed', 'description': '5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed', 'interventionNames': ['Other: Working Memory Training']}], 'interventions': [{'name': 'Working Memory Training', 'type': 'OTHER', 'otherNames': ['Cogmed'], 'armGroupLabels': ['Adaptive Cogmed', 'Non-Adaptive Cogmed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'M.I.N.D. Institute, U.C. Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'David Hessl', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}