Clinical trial NCT07019493: Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke
Official title: Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke Patients
Stroke
Stroke; Sequelae
Young Adults
Keywords: recovery
young stroke
ischemic stroke
hemorrhagic stroke
poststroke fatigue
post-stroke cognitive impairment
function
mood
Lead sponsor: The Florey Institute of Neuroscience and Mental Health
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: University of Newcastle, Australia
name: Austin Health
name: La Trobe University
name: The Alfred
First posted: 2025-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adult stroke survivors within 1 month of stroke

Brief summary: We 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. Our 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. We'll 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, we'll 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 help us prepare for larger studies in the future.


Eligibility criteria: 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

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

Primary outcomes:
measure: Implementability (feasibility, fidelity and acceptability)
timeFrame: From enrolment to the six month assessment visit
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: 6 months
measure: Visual Analogue Scale to Assess Fatigue (VAS-F)
timeFrame: Assessment at <1, 3- and 6-months post stroke
measure: Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue
timeFrame: 6 months
measure: Cognitive Assessment
timeFrame: 6 months
measure: modified Rankin Scale (mRS)
timeFrame: 6 months
measure: 10 metre walk test (10mWT)
timeFrame: 6 months
measure: Visual Analogue Scale of the Impact of Fatigue on Communication Ability
timeFrame: 6 months
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre
state: Victoria
Study officials:
affiliation: Florey Institute of Neuroscience and Mental Health
name: Vincent Thijs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: