Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 2:48 AM
Study NCT ID:
NCT07019493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implementability (feasibility, fidelity and acceptability)', 'timeFrame': 'From enrolment to the six month assessment visit', 'description': "Evaluation of the implementability will include assessment of the protocol's:\n\n* Feasibility, e.g.\n\n * Recruitment rate\n * Retention\n * Proportion of participants screened that enrolled\n * Safety via adverse events\n* Fidelity, e.g.\n\n * Proportion of assessments attended\n * Proportion of data collected and biobanked or analysed\n* Acceptability, e.g. o Participant acceptability surveys"}], 'secondaryOutcomes': [{'measure': 'Fatigue Severity Scale', 'timeFrame': '6 months', 'description': 'FSS: A 9-item (or 7-item with the first two items removed) measure of fatigue impairment.\n\nMeasured at baseline (\\<1month post stroke), 3- and 6-months post stroke.'}, {'measure': 'Visual Analogue Scale to Assess Fatigue (VAS-F)', 'timeFrame': 'Assessment at <1, 3- and 6-months post stroke', 'description': '18-item visual analogue scale of fatigue and energy items.'}, {'measure': 'Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue', 'timeFrame': '6 months', 'description': 'A multidimensional 21-item measure that evaluates physical, psychological and cognitive aspects of fatigue. Measured at baseline (\\<1month post stroke), 3- and 6-months post stroke.'}, {'measure': 'Cognitive Assessment', 'timeFrame': '6 months', 'description': 'Assessment to evaluate cognitive domains such as visuospatial memory, auditory verbal learning, visual attention, task switching, verbal fluency, and verbal short-term and working memory. Assessment \\<1-month, 3- and 6-months post stroke.'}, {'measure': 'modified Rankin Scale (mRS)', 'timeFrame': '6 months', 'description': 'Single-item evaluation of global disability. Assessed at \\<1-month, 3- and 6-months post stroke'}, {'measure': '10 metre walk test (10mWT)', 'timeFrame': '6 months', 'description': 'Gait assessment, evaluated \\<1-month, 3- and 6-months post stroke'}, {'measure': 'Visual Analogue Scale of the Impact of Fatigue on Communication Ability', 'timeFrame': '6 months', 'description': 'Visual analogue scale (0-10) assessing the impact of fatigue on communication ability.\n\nMeasured at baseline (\\<1month post stroke), 3- and 6-months post stroke.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recovery', 'young stroke', 'ischemic stroke', 'hemorrhagic stroke', 'poststroke fatigue', 'post-stroke cognitive impairment', 'function', 'mood'], 'conditions': ['Stroke Patients', 'Stroke', 'Stroke; Sequelae', 'Young Adults']}, 'descriptionModule': {'briefSummary': 'We are running a small, early-phase research study across several hospitals in Melbourne, Australia. The study will involve up to 100 young adults between the ages of 18 and 55 who have had a stroke. Our goal is to test how practical it is to carry out a detailed health assessment process-called "deep phenotyping"-with this group.\n\nThis process involves collecting a wide range of information and samples from stroke survivors to better understand each participant\'s condition. We\'ll look at how well this approach works in practice, including how easy it is to use, whether it\'s done consistently, and how acceptable it is to participants.\n\nAt the same time, we\'ll also explore how different factors-such as biological markers (biomarkers), age, sex, type of stroke, lifestyle, and environment-might be related to stroke recovery. This pilot study will help us prepare for larger studies in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young adult stroke survivors within 1 month of stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between 18 and 55 years.\n2. Within one month of acute stroke confirmed with standard of care brain imaging or clinical diagnosis\n\nExclusion Criteria:\n\n1. Severe, intercurrent or progressive illness likely to EITHER\n\n 1. Have a prognosis for survival under 24 months; OR\n 2. In the opinion of the investigator will mask the importance to the individual participant data (e.g. severe MS, dementia, etc)\n2. Major psychiatric condition requiring medical intervention'}, 'identificationModule': {'nctId': 'NCT07019493', 'briefTitle': 'Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The Florey Institute of Neuroscience and Mental Health'}, 'officialTitle': 'Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke', 'orgStudyIdInfo': {'id': 'Protocol One YSSDP'}, 'secondaryIdInfos': [{'id': 'RARUR000042', 'type': 'OTHER_GRANT', 'domain': 'Medical Research Future Fund (Australia)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young adult stroke survivors (age 18 to 55 inclusive)', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'Not applicable: Observational cohort study', 'armGroupLabels': ['Young adult stroke survivors (age 18 to 55 inclusive)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Emily Ramage', 'role': 'CONTACT', 'email': 'emily.ramage@florey.edu.au', 'phone': '+61 390357000'}, {'name': 'Vincent Thijs', 'role': 'CONTACT', 'email': 'vincent.thijs@florey.edu.au', 'phone': '+61 390357000'}, {'name': 'Vincent Thijs', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}], 'centralContacts': [{'name': 'Emily Ramage, BPhysio, PhD', 'role': 'CONTACT', 'email': 'emily.ramage@florey.edu.au', 'phone': '+61 3 90357000'}, {'name': 'Marie Ferraro, BSc', 'role': 'CONTACT', 'email': 'marie.ferraro@student.unimelb.edu.au', 'phone': '+61390357000'}], 'overallOfficials': [{'name': 'Vincent Thijs, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florey Institute of Neuroscience and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing of individual patient data will be considered upon reasonable request by qualified researchers with appropriate IRB/HREC approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Florey Institute of Neuroscience and Mental Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Melbourne', 'class': 'OTHER'}, {'name': 'University of Newcastle, Australia', 'class': 'OTHER'}, {'name': 'Austin Health', 'class': 'OTHER_GOV'}, {'name': 'La Trobe University', 'class': 'OTHER'}, {'name': 'The Alfred', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}