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NCT Number: NCT05708807

FIND Stroke Recovery - A Longitudinal Study

Stroke survivors frequently suffer disabilities including motor and cognitive problems, impairments in speech and vision, depression, and several other disabilities that worsen their quality of life. Some will recover fully after stroke and others will have permanent impairments. Few studies show trajectories of recovery in different domains after stroke, hence recovery time-lines are not fully known. Also, the whole range of mechanisms leading to recovery are not precisely known (1). To monitor those mechanisms one can utilize biomarkers.

In parallel to the studies of recovery, studies on time series of biomarkers after stroke are limited (2). Hence, a crucial first step to increase knowledge on biomarkers of stroke recovery is to gain a better understanding of the time course of both stroke recovery and biomarker patterns. Biomarkers can later be used for outcome predictions after stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Hemorrhagic Stroke Ischemic Stroke Mental Disorders Nervous System Diseases Neurocognitive Disorders Risk Factor, Cardiovascular Stroke Hemorrhagic Stroke, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital

Gothenburg, SE-41345, Sweden

Location status: Recruiting

Location contact

Christina Jern, MD, PhD

CONTACT

[email protected]

031-3435720

About this study

BACKGROUND

Stroke survivors frequently suffer disabilities including motor and cognitive problems, impairments in speech and vision, depression, and several other disabilities that worsen their quality of life. Some will recover fully after stroke and others will have permanent impairements. Few studies show trajectories of recovery in different domains after stroke, hence recovery time-lines are not fully known. Also, the whole range of mechanisms leading to recovery are not precisely known (1). To monitor those mechanisms one can utilize biomarkers.

In parallel to the studies of recovery, studies on time series of biomarkers after stroke are limited (2). Hence, a crucial first step to increase knowledge on biomarkers of stroke recovery is to gain a better understanding of the time course of both stroke recovery and biomarker patterns. Biomarkers can later be used for outcome predictions after stroke.

WORK PLAN

AIM Determine temporal profiles describing the speed, order, and degree of recovery in neurological and cognitive functions in various domains with simultaneous profiling of changes in blood biomarker concentrations, in the acute, subacute phases and long-term of stroke. Determine individual and interindividual variations in recovery in the different domains.

Informed consent Written informed consent will be obtained from all willing participants or their next-of-kin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Investigators enrol patients presenting with first-ever ischemic stroke or intracerebral haemorrhage admitted to the stroke units at the Sahlgrenska University Hospital in Gothenburg, Sweden.

The inclusion criteria are:

  • first-ever acute ischemic stroke; or intracerebral hemorrhage.

The exclusion criteria are:

  • pre-stroke mRS score of ≥3;
  • severe neurodegenerative disease, cerebral neoplasm or terminal illness; and
  • patients considered unlikely to be able to participate in or to understand and/or comply with study procedures during follow-up visits at the hospital.

Treatment and study plan

Observational - all

Other

All stroke patients are included.

Primary outcomes

  1. Medical data Clinical data

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.

    Stroke subtype, medical history, life style questions between baseline and follow-ups

  2. Stroke severity

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.

    Change of National Institutes of Health Stroke Scale (NIHSS) between baseline and follow-ups.

  3. Functional independence

    Time frame: Pre-stroke estimation, baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.

    Change of modified Ranking Scale (mRS) functional independence

  4. Walking ability

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.

    Change in functional Ambulation Category between baseline and follow ups.

  5. Postural control

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.

    Change in postural control, evaluated by Berg Balance Scale (BBS), between baseline and follow ups.

  6. Blood samples

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Analyses of plasma protein levels and circulating RNA profiles in comparison to baseline

  7. FMA-arm test

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in performance on Fugl-Meyer Assessment of Motor Recovery after Stroke test between baseline and follow-up.

  8. SAFE

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in performance on Shoulder Abduction and Finger Extension (SAFE) score between baseline and follow ups.

  9. MoCA

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in the Montreal Cognitive Assessment between baseline and follow ups.

  10. Neuroimaging

    Time frame: Baseline, and change from baseline at 3, and 12 months; 2 years

    Changes in MRI scans between baseline and follow-ups.

  11. D-FIS

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in the Daily Fatigue Impact Scale (D-FIS) between baseline and follow ups.

  12. HAD

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in the Hospital Anxiety and Depression (HAD) scale between baseline and follow ups.

  13. SIS

    Time frame: Baseline, and change from baseline and 3, 6 and 12 months; 2 and 5 years

    Change in domains of Stroke Impact Scale (SIS) between baseline and follow ups.

  14. FAS

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in the Verbal Fluency Test between baseline and follow ups.

  15. CWT

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in the Color-Word Interference test between baseline and follow ups.

  16. TMT

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in the Trail Making Test between baseline and follow ups.

  17. RBANS

    Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

    Change in the 10-word test from Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) between baseline and follow ups.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Jern, MD, PhD

CONTACT

[email protected]

+46-31-3435720

Jood Katarina, MD, PhD

CONTACT

[email protected]

+46-31-342 90 52

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

FIND Stroke Recovery: A Longitudinal Frequent Evaluation Long-term Follow-up Study

Acronym: FIND

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Feb 1, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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