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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Young Adults; Stroke Patients; Stroke; Sequelae
• Intervention / Treatment: Other: Observational Cohort

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Emily Ramage, BPhysio, PhD; Phone Number: +61 3 90357000; Email: emily.ramage@florey.edu.au
• Study Contact Backup: Name: Marie Ferraro, BSc; Phone Number: +61390357000; Email: marie.ferraro@student.unimelb.edu.au

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3039
      • Recruiting
      • Austin Health
      • Contact: Vincent Thijs; Phone Number: 9035 7000; Email: emily.ramage@wh.org.au
      • Contact: Email: emily.ramage@florey.edu.au
    • Heidelberg, Victoria, Australia, 3084
      • Not yet recruiting
      • Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre
      • Principal Investigator: Vincent Thijs
      • Contact: Emily Ramage; Phone Number: +61 390357000; Email: emily.ramage@florey.edu.au
      • Contact: Vincent Thijs; Phone Number: +61 390357000; Email: vincent.thijs@florey.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Young adult stroke survivors within 3 months of stroke

Description

Inclusion Criteria:

1. Between 18 and 55 years.
2. 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

Exclusion Criteria:

1. Severe, intercurrent or progressive illness likely to EITHER

   1. Have a prognosis for survival under 24 months; OR
   2. In the opinion of the investigator will mask the importance to the individual participant data (e.g. severe MS, dementia, etc)
2. Major psychiatric condition requiring medical intervention

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Young adult stroke survivors (age 18 to 55 inclusive)

Other: Observational Cohort; 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.; Other Names: Deep phenotyping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementability (feasibility, fidelity and acceptability)	Evaluation of the implementability will include assessment of the protocol's: Feasibility, e.g.Recruitment rateRetentionProportion of participants screened that enrolledSafety via adverse events; Fidelity, e.g.Proportion of assessments attendedProportion of data collected and biobanked or analysed; Acceptability, e.g. o Participant acceptability surveys	From enrolment to the six month assessment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Visual Analogue Scale to Assess Fatigue (VAS-F)	18-item visual analogue scale of fatigue and energy items.	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.	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.	6 months
modified Rankin Scale (mRS)	Single-item evaluation of global disability. Assessed at <1-month, 3- and 6-months post stroke	6 months
10 metre walk test (10mWT)	Gait assessment, evaluated <1-month, 3- and 6-months post stroke	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.	6 months

Collaborators and Investigators

• Sponsor: The Florey Institute of Neuroscience and Mental Health
• Collaborators: The Alfred; Austin Health; University of Melbourne; University of Newcastle, Australia; La Trobe University
• Investigators: Principal Investigator: Vincent Thijs, MD, PhD, Florey Institute of Neuroscience and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 30, 2025
• First Submitted That Met QC Criteria: June 5, 2025
• First Posted (Actual): June 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: recovery; function; ischemic stroke; mood; hemorrhagic stroke; poststroke fatigue; post-stroke cognitive impairment; young stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Hemorrhagic Stroke; Stroke
• Other Study ID Numbers: Protocol One YSSDP; RARUR000042 (Other Grant/Funding Number: Medical Research Future Fund (Australia))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Sharing of individual patient data will be considered upon reasonable request by qualified researchers with appropriate IRB/HREC approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No