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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational - all | All included stroke patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational - all | Other | All stroke patients are included. |
|
| 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. |
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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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Jern, MD, PhD | Contact | +46-31-3435720 | christina.jern@neuro.gu.se | |
| Jood Katarina, MD, PhD | Contact | +46-31-342 90 52 | katarina.jood@neuro.gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Christina Jern, MD, PhD | Inst. of Biomedicine, the Sahlgrenska Academy, Univ. of Gothenburg | Principal Investigator |
| Turgut Tatlisumak, MD, PhD | Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital | Recruiting | Gothenburg | SE-41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16713245 | Background | Wieloch T, Nikolich K. Mechanisms of neural plasticity following brain injury. Curr Opin Neurobiol. 2006 Jun;16(3):258-64. doi: 10.1016/j.conb.2006.05.011. Epub 2006 May 18. | |
| 25276489 | Background | Doll DN, Barr TL, Simpkins JW. Cytokines: their role in stroke and potential use as biomarkers and therapeutic targets. Aging Dis. 2014 Oct 1;5(5):294-306. doi: 10.14336/AD.2014.0500294. eCollection 2014 Oct. |
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Anonymized data may be shared by qualified academic research collaborators as long as data transfer is in agreement with EU legislation on the general data protection regulation and decisions by the Ethical Review Board of Sweden and the University of Gothenburg, which should be regulated in a data transfer agreement.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083302 | Hemorrhagic Stroke |
| D000083242 | Ischemic Stroke |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Protocol At admission participants undergo adequate neuroimaging and additional work-up according to clinical routine and answer questionaries on medical history, education, occupancy, pre-stroke functionality and donate blood samples. At 3 and 6 months and 1, 2 and 5 years the participants come for follow ups where they undergo substantial testing on cognition and motor function in parallel they also answer questionaries on mood, health, participation and recovery and donate blood samples. A detailed protocol will be published as a "study protocol".
Biomarkers Blood samples are transferred to the Biobank West, Sahlgrenska University Hospital, Region Västra Götaland, where samples will be aliquoted and stored at -80 °C in a locked space, further details in the full study protocol.
| 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 |
| Katarina Jood, MD, PhD | Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg | Principal Investigator |
| 37164469 | Derived | Brannmark C, Klasson S, Stanne TM, Samuelsson H, Alt Murphy M, Sunnerhagen KS, Aberg ND, Jalnefjord O, Bjorkman-Burtscher I, Jood K, Tatlisumak T, Jern C. FIND Stroke Recovery Study (FIND): rationale and protocol for a longitudinal observational cohort study of trajectories of recovery and biomarkers poststroke. BMJ Open. 2023 May 10;13(5):e072493. doi: 10.1136/bmjopen-2023-072493. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |