Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-01 @ 1:39 AM
Study NCT ID:
NCT06700005
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ReadMap: Reading in Stroke Alexia and Typical Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D004410', 'term': 'Dyslexia'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D007802', 'term': 'Language'}, {'id': 'D001072', 'term': 'Apraxias'}], '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': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)', 'timeFrame': 'Collected within 1 month of behavioral testing', 'description': 'Part of MRI sequence that measures deep grey matter structure.'}, {'measure': 'DTI (Diffusion Tensor Imaging)', 'timeFrame': 'Collected within 1 month of behavioral testing', 'description': 'Part of MRI sequence that measures the rate of water diffusion between cells to understand and create a map of internal structures.'}, {'measure': 'Behavioral testing', 'timeFrame': 'Collected within 1 month of MRI', 'description': 'Battery of standard clinical and in-house behavioral tests to measure speech, language, and cognition. Final score is derived from principle components analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aphasia', 'stroke', 'brain injury', 'speech', 'language', 'reading', 'alexia', 'apraxia'], 'conditions': ['Aphasia', 'Stroke', 'Alexia']}, 'descriptionModule': {'briefSummary': "Loss of reading ability due to stroke, called alexia, likely affects over a million Americans at any given time and causes difficulty performing many daily life functions, such as paying bills, using email/text, reading for pleasure, and reading signs in the community. Understanding the brain and cognitive basis of alexia could improve diagnosis and treatment of this important problem. In this study, the investigators will perform a large-scale behavioral and brain imaging study of stroke survivors and typical older adults to improve our understanding of the brain and cognitive basis of reading in both of these groups.\n\nParticipants will complete a battery of tests of reading, speech, language, and thinking abilities. In addition, some participants will complete an MRI. Sessions will be completed across approximately 2-6 weeks, but may be extended depending on participants' schedules and availability. Some participants will be invited to repeat these procedures once or twice in approximately 3-12 months to monitor for changes in reading abilities and MRI measurements over time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are survivors of left hemisphere stroke with or without reading difficulties, or people with aphasia or alexia due to strokes in other parts of the brain. The investigators recruit participants primarily from the Washington, DC region, but some participants may travel from farther away to participate in the study. The investigators aim for our participants to be fully representative of the diversity of individuals with stroke in the general population.\n\nControl participants have not had a stroke or other brain injury, and are matched to stroke survivors on age, gender, race, educational background, and stroke risk factors.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nStroke Survivors:\n\n* Age \\>= 18\n* Learned English at 8 years or younger\n* Brain injury resulting from stroke\n\nControls:\n\n* Age \\>= 18\n* Learned English at 8 years or younger\n\nExclusion criteria for all groups:\n\n* History of other brain disorder that could interfere with our ability to interpret results (e.g., Multiple sclerosis, dementia, head injury causing loss of consciousness)\n* Severe psychiatric condition that would interfere with participation in the study\n* History of diagnosed learning disorder\n* Hearing or vision loss that interferes with performance on behavioral tests even after correction with glasses/hearing aids.\n* Inability to follow study procedures despite maximal support\n\nAdditional exclusion criteria for MRIs:\n\n* Presence of metal in the body that is incompatible with MRI\n* Pregnancy\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT06700005', 'acronym': 'ReadMap', 'briefTitle': 'ReadMap: Reading in Stroke Alexia and Typical Aging', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'ReadMap: Reading in Stroke Alexia and Typical Aging', 'orgStudyIdInfo': {'id': 'ReadMap'}, 'secondaryIdInfos': [{'id': 'R01DC020446', 'link': 'https://reporter.nih.gov/quickSearch/R01DC020446', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke Survivors', 'description': 'Participants have had a left-hemisphere stroke, or a stroke elsewhere in the brain causing aphasia or alexia (i.e., reading difficulties). They are given a series of standardized and in-house tests of reading, language and cognition to provide a detailed profile of strengths and weaknesses, plus an MRI.'}, {'label': 'Controls', 'description': 'Participants are matched to the stroke cohort in age, educational background, race, and gender but have no history of brain injury. They are also given a series of standardized and in-house tests of reading, language and cognition to provide a detailed profile of strengths and weaknesses, plus an MRI.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alycia Laks, MS, CCC-SLP', 'role': 'CONTACT', 'email': 'crlab@georgetown.edu', 'phone': '202-687-5205'}], 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Alycia Laks, MS, CCC-SLP', 'role': 'CONTACT', 'email': 'crlab@georgetown.edu', 'phone': '202-687-5205'}], 'overallOfficials': [{'name': 'Peter Turkeltaub, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University; MedStar National Rehabilitation Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MedStar National Rehabilitation Network', 'class': 'OTHER'}, {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}