FIND Stroke Recovery - A Longitudinal Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Risk Factor, Cardiovascular, Cognitive Impairment

Intervention / Treatment
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* Other: Observational - all


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational - all<br>All included stroke patients. | Other: Observational - all<br>* All stroke patients are included.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical data Clinical data | Stroke subtype, medical history, life style questions between baseline and follow-ups | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years. | 
| Stroke severity | Change of National Institutes of Health Stroke Scale (NIHSS) between baseline and follow-ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years. | 
| Functional independence | Change of modified Ranking Scale (mRS) functional independence | Pre-stroke estimation, baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years. | 
| Walking ability | Change in functional Ambulation Category between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years. | 
| Postural control | Change in postural control, evaluated by Berg Balance Scale (BBS), between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years. | 
| Blood samples | Analyses of plasma protein levels and circulating RNA profiles in comparison to baseline | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| FMA-arm test | Change in performance on Fugl-Meyer Assessment of Motor Recovery after Stroke test between baseline and follow-up. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| SAFE | Change in performance on Shoulder Abduction and Finger Extension (SAFE) score between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| MoCA | Change in the Montreal Cognitive Assessment between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| Neuroimaging | Changes in MRI scans between baseline and follow-ups. | Baseline, and change from baseline at 3, and 12 months; 2 years | 
| D-FIS | Change in the Daily Fatigue Impact Scale (D-FIS) between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| HAD | Change in the Hospital Anxiety and Depression (HAD) scale between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| SIS | Change in domains of Stroke Impact Scale (SIS) between baseline and follow ups. | Baseline, and change from baseline and 3, 6 and 12 months; 2 and 5 years | 
| FAS | Change in the Verbal Fluency Test between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| CWT | Change in the Color-Word Interference test between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| TMT | Change in the Trail Making Test between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 
| RBANS | Change in the 10-word test from Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) between baseline and follow ups. | Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recovery, rehabilitation, stroke severity, plasticity, modified Rankin Scale, National Institutes of Health Stroke Scale, Fugl-Meyer assessment, blood sampling, stroke subtype