Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke

NCT07019493 | Recruiting

• 2 other identifiers: Protocol One YSSDPRARUR000042
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

recovery; young stroke; ischemic stroke; hemorrhagic stroke; poststroke fatigue; post-stroke cognitive impairment; function; mood

Outcome Measures

Primary Outcomes (1)

• 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

  From enrolment to the six month assessment visit

Secondary Outcomes (7)

• Fatigue Severity Scale

  6 months

• Visual Analogue Scale to Assess Fatigue (VAS-F)

  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

  6 months

• Cognitive Assessment

  6 months

• modified Rankin Scale (mRS)

  6 months

Study Arms (1)

Young adult stroke survivors (age 18 to 55 inclusive)

Other: Observational Cohort

Interventions

Observational Cohort OTHER

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.

Also known as: Deep phenotyping

Young adult stroke survivors (age 18 to 55 inclusive)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young adult stroke survivors within 3 months of stroke

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Florey Institute of Neuroscience and Mental Health: lead
• University of Newcastle, Australia: collaborator
• Austin Health: collaborator
• La Trobe University: collaborator
• The Alfred: collaborator
• University of Melbourne: collaborator

Study Sites (2)

Austin Health

Heidelberg, Victoria, 3039, Australia

RECRUITING

Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vincent Thijs, MD, PhD

  Florey Institute of Neuroscience and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Ramage, BPhysio, PhD

CONTACT

+61 3 90357000; emily.ramage@florey.edu.au

Marie Ferraro, BSc

CONTACT

+61390357000; marie.ferraro@student.unimelb.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 13, 2025
• Study Start: July 19, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

AU (2)