Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT07206433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transient Ischemic Attack (TIA) and Spoken Language
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'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'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech rate', 'timeFrame': 'From enrollment', 'description': 'measured as number of words per minute'}, {'measure': 'Mean length of sentence', 'timeFrame': 'From enrollment', 'description': 'measured in number of words'}, {'measure': 'Sentence complexity', 'timeFrame': 'From enrollment', 'description': 'measured as number of complex sentences'}, {'measure': 'Functional Memory Questionnaire', 'timeFrame': 'From enrollment', 'description': 'Patient-reported measure of perceptions of memory, attention, language abilities;\n\nscore range 0 to 140; higher scores mean a worse outcome'}, {'measure': 'Communication Confidence Rating Scale for Aphasia', 'timeFrame': 'From enrollment', 'description': 'Patient-reported measure of confidence of communication abilities;\n\nscore range 0 to 600; higher scores mean worse outcome'}], 'secondaryOutcomes': [{'measure': 'Filled pause rate', 'timeFrame': 'From enrollment', 'description': 'Number of filled paused (i.e., "um" "uh", "ehm") over total number of words'}, {'measure': 'Lexical richness', 'timeFrame': 'From enrollment', 'description': 'measured as number of unique words over total number of words'}, {'measure': 'Propositional idea density', 'timeFrame': 'From enrollment', 'description': 'using the Computerized Propositional Idea Density Rater - CPIDER3 - Brown et al. (2008)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TIA', 'Transient Ischemic Attack', 'speech', 'language'], 'conditions': ['TIA (Transient Ischemic Attack)']}, 'descriptionModule': {'briefSummary': "Transient Ischaemic Attack (also known as TIA or 'mini-stroke') affects about 46,000 people in the UK each year. It is assumed that people recover fully within 24 hours. However, subtle problems with speaking, and confidence with their communication skills can be long-term. This project will be the first in depth exploration of speaking abilities after recent TIA where there seemed to be a full recovery.\n\nThe researchers will look for 90 volunteers for detailed testing. Thirty people who have had a TIA for the first time. For comparisons, the researchers will also include 60 volunteers without TIA (30 treated to prevent TIA and stroke; 30 who do not receive prevention treatments).\n\nAims and methods:\n\n1. To find out if TIA makes speaking difficult.\n\n People will complete speaking tasks in a quiet place. For example, people will be asked to tell us about their weekend, what they think about climate change.\n2. To find out if people are concerned about their speech and other thinking skills after TIA.\n\n People will fill in questionnaires to help us look into these issues.\n3. To find out if speaking abilities and people's own views of their communication change over time (about three months after the TIA).\n\nDiscovering new knowledge about spoken communication after a TIA diagnosis could change the course of TIA research and care across health professions (speech-language therapy, psychology, audiology, neurology). Future studies could use speaking tasks to scrutinise further the complexity of subtle communication problems after TIA and determine which individuals are likely to have these problems. The project will raise understanding of these issues, enabling affected individuals to seek professional support. Finally, it will also guide development of new TIA recommendations and treatments for these problems thus improving people's quality of life.", 'detailedDescription': 'Montreal Cognitive Assessment (MoCA; (Nasreddine et al., 2005): Assesses general cognitive function; reliable and valid; different versions for repeated assessment (e.g., sentence repetition "I only know that John is the one to help today"; You\'ll hear a list of numbers and I\'d like you to repeat them in the order you heard them).\n\nEveryday Memory Questionnaire (Sunderland et al., 1986): Self-reported measure of cognitive skills many of which are about communication, language and reading (Likert scale) (e.g., forgetting the names of friends or relatives or calling them by the wrong names; getting lost or turning in the wrong direction on a journey or walk you have often been on).\n\nData analyses\n\nFor aims 1 and 2, the methods of analysis for each of the outcome measures is detailed below and will be in conducted in R.\n\nDescriptive statistics by subgroup (medians, range, inter-quartile range) will be generated for each outcome measure (speech-related \\[primary, secondary\\], Everyday Memory Questionnaire, Communication Confidence Rating Scale for Aphasia).\n\nKruskal-Wallis non-parametric analysis of variance will be carried out for each outcome measure (alpha level .05). Post-hoc pairwise comparisons (using Dunn\'s test correction for multiple comparisons) for statistically significant results. Effect sizes will also be obtained.\n\nCommunication Confidence Rating Scale for Aphasia (Cherney et al., 2011): Self-reported confidence in communication activities (Likert scale) (e.g., how confident are you about your ability to talk with people? How confident are you that people understand you when you talk?)\n\nConnected speech assessment tasks (Whitworth et al., 2015): Assesses connected speech skills, (e.g., can you tell me what you did last weekend? Can you remember a recent celebration such as a birthday, anniversary, wedding or party that you have been to? Can you tell me about it? What do you think about global warming and why?)\n\nFor aim 3, descriptive statistics (as above) will be generated for each outcome measure non-parametric Wilcoxon tests (alpha level 0.5) will be used. Effect sizes will also be obtained. These analyses will also be carried out in R.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'TIA group: Individuals who have had a recent single medically confirmed TIA following an in-person review at a TIA clinic.\n\nVascular risk factor group: People aged 40-75 with vascular risk factors (e.g., hypertension, diabetes, hyperlipidemia) who receive medical treatment for these conditions and have attended a TIA clinic but were not diagnosed with a TIA.\n\nHealthy group: People aged 40-75 who have no self-reported vascular risk factors for which they take medication.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria: People aged 40-85 with a diagnosis of a single carotid circulation TIA.\n\nExclusion Criteria:\n\nYounger than 40 years or older than 85 years of age.\n\nEnglish as a secondary language.\n\nNeurological conditions affecting cognitive function (e.g., Parkinson's disease, dementia, stroke).\n\nSelf-reported, pre-existing speech or cognitive problems, developmental or acquired.\n\nDemonstrate noticeable difficulties carrying out project-related tasks."}, 'identificationModule': {'nctId': 'NCT07206433', 'briefTitle': 'Transient Ischemic Attack (TIA) and Spoken Language', 'organization': {'class': 'OTHER', 'fullName': 'Newcastle University'}, 'officialTitle': 'Identification and Perceptions of Spoken Language Abilities After Transient Ischaemic Attack (TIA): An Exploratory, Longitudinal Study', 'orgStudyIdInfo': {'id': 'TIASPEECHPROTOCOL3132025'}}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 7RU', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'contacts': [{'name': 'Christos Salis, PhD', 'role': 'CONTACT', 'email': 'christos.salis@newcastle.ac.uk', 'phone': '+441912088875'}], 'facility': 'Newcastle University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'centralContacts': [{'name': 'Christos Salis, PhD', 'role': 'CONTACT', 'email': 'christos.salis@ncl.ac.uk', 'phone': '+441912088875'}, {'name': 'Janet Webster, PhD', 'role': 'CONTACT', 'email': 'janet.webster@ncl.ac.uk', 'phone': '+441912085235'}], 'overallOfficials': [{'name': 'Christos Salis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newcastle University'}, {'name': 'Lisa Shaw, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Newcastle University'}, {'name': 'Christopher Price, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Newcastle University'}, {'name': 'Mahmoud Kargar, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Newcastle University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newcastle University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northumbria Healthcare NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}