Stroke PatientsNCT07019493
Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke
An observational study of Stroke Patients and Stroke, run by The Florey Institute of Neuroscience and Mental Health at 2 sites in Australia.
Trial summary
The Investigators 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Stroke Patients, Stroke, Stroke; Sequelae
- What is being tested?
- Observational Cohort
- How many people
- 100 participants
- Where
- 2 sitesAustralia
- Study dates
- 19 Jul 2025to Dec 2027
- Phase
- Observational
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adult stroke survivors within 3 months of stroke
Who may be able to join
- Between 18 and 55 years.
- Within one month of acute stroke confirmed with standard of care brain imaging or clinical diagnosis or for those for whom recruitment <1 month of stroke is not possible they may be recruited to participate within 3-months of stroke
Who cannot join
- Severe, intercurrent or progressive illness likely to EITHER
- Have a prognosis for survival under 24 months; OR
- In the opinion of the investigator will mask the importance to the individual participant data (e.g. severe MS, dementia, etc)
- Major psychiatric condition requiring medical intervention
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Austin Health
Heidelberg, Victoria, 3039
Vincent Thijs, 9035 7000, emily.ramage@wh.org.au
emily.ramage@florey.edu.au
- Not yet recruiting
Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre
Heidelberg, Victoria, 3084
Emily Ramage, +61 390357000, emily.ramage@florey.edu.au
Vincent Thijs, +61 390357000, vincent.thijs@florey.edu.au
About this study
The Investigators 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. The goal is to test how practical it is to carry out a detailed health assessment process-called "deep phenotyping"-with this group.
This process involves collecting a wide range of information and samples from stroke survivors to better understand each participant's condition. The Investigators will 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.
At the same time, the Investigators will 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 prepare for larger studies in the future.
- Conditions
- Stroke Patients, Stroke, Stroke; Sequelae, Young Adults
- Being tested
- Observational Cohort
- Keywords
- recovery, young stroke, ischemic stroke, hemorrhagic stroke, poststroke fatigue, post-stroke cognitive impairment, function, mood
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational CohortOther
Also called Deep phenotyping
The deep phenotyping observational study observes young adult stroke recovery trajectories and will also explore potential recovery biomarkers via: advanced MRI imaging; samples including blood, saliva, urine and hair stored for future analysis that may include (but is not limited to) proteomics, genomics and cortisol; and, a PET scan sub study involving ~20 participants (additional inclusion criteria) exploring the association of reactive astrogliosis with recovery outcomes using the experimental Positron Emission Tomography 18F-SMBT-1 tracer (AU TGA CTN in place).
Associations with personal and environmental factors including: physical activity and sleep quality via device (Actigraph and Somfit) and self-report; exposures such as home and work environments, diet, socioeconomic status, and dental health; quality of life, resilience, and locus of control.
Monitor healthcare utilisation, changes in medication and medical condition, participant experience and response to the assessments.
| Study group | Role | What they receive |
|---|---|---|
| Young adult stroke survivors (age 18 to 55 inclusive) | Not described Receives: Other: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementability (feasibility, fidelity and acceptability)
Evaluation of the implementability will include assessment of the protocol's:
- Feasibility, e.g.
- Recruitment rate
- Retention
- Proportion of participants screened that enrolled
- Safety via adverse events
- Fidelity, e.g.
- Proportion of assessments attended
- Proportion of data collected and biobanked or analysed
- Acceptability, e.g. o Participant acceptability surveys
Measured: From enrolment to the six month assessment visit
Secondary outcomes (7)
Fatigue Severity Scale
FSS: A 9-item (or 7-item with the first two items removed) measure of fatigue impairment.
Measured at baseline (<1month post stroke), 3- and 6-months post stroke.
Measured: 6 months
Visual Analogue Scale to Assess Fatigue (VAS-F)
18-item visual analogue scale of fatigue and energy items.
Measured: Assessment at <1, 3- and 6-months post stroke
Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue
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.
Measured: 6 months
Cognitive Assessment
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.
Measured: 6 months
modified Rankin Scale (mRS)
Single-item evaluation of global disability. Assessed at <1-month, 3- and 6-months post stroke
Measured: 6 months
10 metre walk test (10mWT)
Gait assessment, evaluated <1-month, 3- and 6-months post stroke
Measured: 6 months
Visual Analogue Scale of the Impact of Fatigue on Communication Ability
Visual analogue scale (0-10) assessing the impact of fatigue on communication ability.
Measured at baseline (<1month post stroke), 3- and 6-months post stroke.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start19 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Florey Institute of Neuroscience and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, University of Newcastle, Australia, Austin Health, La Trobe University, The Alfred
- Responsible party
- Sponsor
- Investigators
- Vincent Thijs, MD, PhD, Principal investigator, The Florey Institute of Neuroscience and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019493
- Sponsor's protocol ID
- Protocol One YSSDP
- Other IDs
- RARUR000042
- Status last verified
- Apr 2026
- First submitted
- 30 May 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of individual patient data will be considered upon reasonable request by qualified researchers with appropriate IRB/HREC approval