Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-27 @ 1:44 PM
Study NCT ID:
NCT00827268
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2009-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D004411', 'term': 'Dyslexia, Acquired'}, {'id': 'D004410', 'term': 'Dyslexia'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a repeated probe design study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2009-01-20', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Real World Reading Skills', 'timeFrame': 'Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.', 'description': 'Real World Reading Skills was tested using the Woodcock Reading Mastery Test-Revised'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dyslexia', 'Reading', 'Aphasia', 'Stroke'], 'conditions': ['Aphasia', 'Stroke', 'Dyslexia, Acquired']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://neuropsy.phhp.ufl.edu/facres/facprofiles/Conway.html', 'label': "Dr. Conway's homepage"}]}, 'descriptionModule': {'briefSummary': 'This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.', 'detailedDescription': "The proposed study is a mixed-effects (single-subject ABA repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. The short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with post-stroke reading difficulties (phonological alexia)\n* \\>3 months post-stroke\n* native English speaker\n* can go in MRI scanner (3 to 6 scans),\n* participate in 90 to 120 free treatment sessions\n* return for 3-month post-treatment follow-up assessment \\& MRI.\n\nExclusion Criteria:\n\n* mental illness\n* degenerative disease, visual or auditory acuity impairment\n* drug abuse\n* English is not first language\n* claustrophobia\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00827268', 'briefTitle': 'Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes', 'orgStudyIdInfo': {'id': 'B6699-W'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'description': 'Repeated probes every 8 hours of treatment (1/week)', 'interventionNames': ['Behavioral: One-on-one treatment of reading difficulties']}], 'interventions': [{'name': 'One-on-one treatment of reading difficulties', 'type': 'BEHAVIORAL', 'description': 'Multimodal behavioral treatment focused on retraining sound to letter associations and skills in sounding out words when reading. Treatment has been pilot-tested in published papers since 1998.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida/South Georgia Veterans Health System', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Timothy W. Conway, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Florida/South Georgia Veterans Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}