Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT03662295
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2018-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized assessment', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Aphasia Quotient of the Western Aphasia Battery - Revised'}], 'secondaryOutcomes': [{'measure': 'Spoken picture description', 'timeFrame': 'Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks', 'description': 'Spoken language sample elicited through a request to describe events depicted in a Norman Rockwell drawing.'}, {'measure': 'Written picture description', 'timeFrame': 'Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks', 'description': 'Written language sample elicited through a request to write about events depicted in a Norman Rockwell drawing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Impairment'], 'conditions': ['Migraine Disorders', 'Aphasia']}, 'descriptionModule': {'briefSummary': 'Stroke-like migraine attacks after radiation therapy-also known as SMART syndrome-constitute a rare condition typically characterized by headache, seizures, vision abnormalities, hemiparesis, and aphasia. The condition usually resolves within a few days or weeks of onset with no residual impairments. However, resolution in some cases extends over a period of months rather than weeks and may be incomplete. The purpose of this case report is to provide an in-depth description of the progression of changes in cognitive and language functioning for a person exhibiting SMART syndrome characterized by slow recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One adult with SMART syndrome will participate in this study. The person will have cognitive and language deficits typical of those exhibited by people with SMART syndrome. Given the rarity of the disorder, only one participant is anticipated.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* exhibit cognitive and language deficits secondary to SMART syndrome\n* be a former or current client of Quality Living, Inc., Omaha, Nebraska\n* be a native speaker of English\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03662295', 'briefTitle': 'Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Quality Living, Inc.'}, 'officialTitle': 'Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention', 'orgStudyIdInfo': {'id': 'SMART'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Language treatment', 'type': 'BEHAVIORAL', 'description': 'Individual speech-language therapy sessions totaling 1.5 to 2.5 hours five days per week. Intervention activities include performing oral and written confrontation and responsive naming, writing single words to dictation, reading single words and sentences aloud, and generating written and spoken picture descriptions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68104', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Quality Living, Inc.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Karen Hux, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quality Living, Inc., Omaha, Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quality Living, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research', 'investigatorFullName': 'Karen Hux', 'investigatorAffiliation': 'Quality Living, Inc.'}}}}