TIA (Transient Ischemic Attack)NCT07206433
Transient Ischemic Attack (TIA) and Spoken Language
An observational study of TIA (Transient Ischemic Attack), run by Newcastle University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- TIA (Transient Ischemic Attack)
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: TIA group: Individuals who have had a recent single medically confirmed TIA following an in-person review at a TIA clinic. Vascular 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. Healthy group: People aged 40-75 who have no self-reported vascular risk factors for which they take medication.
Who may be able to join
None listed.
Who cannot join
- Younger than 40 years or older than 85 years of age.
- English as a secondary language.
- Neurological conditions affecting cognitive function (e.g., Parkinson's disease, dementia, stroke).
- Self-reported, pre-existing speech or cognitive problems, developmental or acquired.
- Demonstrate noticeable difficulties carrying out project-related tasks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
Christos Salis, PhD, +441912088875, christos.salis@newcastle.ac.uk
About this study
Official title: Identification and Perceptions of Spoken Language Abilities After Transient Ischaemic Attack (TIA): An Exploratory, Longitudinal Study
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.
The 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).
Read more
Aims and methods:
- To find out if TIA makes speaking difficult. 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.
- To find out if people are concerned about their speech and other thinking skills after TIA. People will fill in questionnaires to help us look into these issues.
- To find out if speaking abilities and people's own views of their communication change over time (about three months after the TIA).
Discovering 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.
Read the detailed description
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).
Everyday 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).
Data analyses
For aims 1 and 2, the methods of analysis for each of the outcome measures is detailed below and will be in conducted in R.
Descriptive 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).
Kruskal-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.
Communication 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?)
Connected 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?)
For 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.
- Conditions
- TIA (Transient Ischemic Attack)
- Keywords
- TIA, Transient Ischemic Attack, speech, language
- Medical subject headings
- Ischemic Attack, Transient, Speech, Language
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech rate
measured as number of words per minute
Measured: From enrollment
Mean length of sentence
measured in number of words
Measured: From enrollment
Sentence complexity
measured as number of complex sentences
Measured: From enrollment
Functional Memory Questionnaire
Patient-reported measure of perceptions of memory, attention, language abilities;
score range 0 to 140; higher scores mean a worse outcome
Measured: From enrollment
Communication Confidence Rating Scale for Aphasia
Patient-reported measure of confidence of communication abilities;
score range 0 to 600; higher scores mean worse outcome
Measured: From enrollment
Secondary outcomes (3)
Filled pause rate
Number of filled paused (i.e., "um" "uh", "ehm") over total number of words
Measured: From enrollment
Lexical richness
measured as number of unique words over total number of words
Measured: From enrollment
Propositional idea density
using the Computerized Propositional Idea Density Rater - CPIDER3 - Brown et al. (2008)
Measured: From enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TIA (Transient Ischemic Attack)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Christos Salis, PhD, Principal investigator, Newcastle UniversityLisa Shaw, MD, Study chair, Newcastle UniversityChristopher Price, MD, Study chair, Newcastle UniversityMahmoud Kargar, MSc, Study chair, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206433
- Sponsor's protocol ID
- TIASPEECHPROTOCOL3132025
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Perceptions of Spoken Language Abilities After Transient Ischaemic Attack (TIA): An Exploratory, Longitudinal Study
- ClinicalTrials.gov ID
- NCT07206433
- Acronym / sponsor ID
- TIASPEECHPROTOCOL3132025
- Conditions
- TIA (Transient Ischemic Attack)
- Keywords
- TIA, Transient Ischemic Attack, speech, language
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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).
Aims and methods:
- To find out if TIA makes speaking difficult. 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.
- To find out if people are concerned about their speech and other thinking skills after TIA. People will fill in questionnaires to help us look into these issues.
- To find out if speaking abilities and people's own views of their communication change over time (about three months after the TIA).
Discovering 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.
Detailed description
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).
Everyday 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).
Data analyses
For aims 1 and 2, the methods of analysis for each of the outcome measures is detailed below and will be in conducted in R.
Descriptive 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).
Kruskal-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.
Communication 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?)
Connected 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?)
For 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- TIA group: Individuals who have had a recent single medically confirmed TIA following an in-person review at a TIA clinic. Vascular 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. Healthy group: People aged 40-75 who have no self-reported vascular risk factors for which they take medication.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Younger than 40 years or older than 85 years of age.
- English as a secondary language.
- Neurological conditions affecting cognitive function (e.g., Parkinson's disease, dementia, stroke).
- Self-reported, pre-existing speech or cognitive problems, developmental or acquired.
- Demonstrate noticeable difficulties carrying out project-related tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Speech rate
Time frame: From enrollment
measured as number of words per minute
Mean length of sentence
Time frame: From enrollment
measured in number of words
Sentence complexity
Time frame: From enrollment
measured as number of complex sentences
Functional Memory Questionnaire
Time frame: From enrollment
Patient-reported measure of perceptions of memory, attention, language abilities; score range 0 to 140; higher scores mean a worse outcome
Communication Confidence Rating Scale for Aphasia
Time frame: From enrollment
Patient-reported measure of confidence of communication abilities; score range 0 to 600; higher scores mean worse outcome
3 secondary outcomes
Filled pause rate
Time frame: From enrollment
Lexical richness
Time frame: From enrollment
Propositional idea density
Time frame: From enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christos Salis, PhD principal investigator
Newcastle University
Lisa Shaw, MD study chair
Newcastle University
Christopher Price, MD study chair
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TIA (Transient Ischemic Attack), run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christos Salis, PhD (+441912088875, christos.salis@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech rate (time frame: From enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.