FIND Stroke Recovery - A Longitudinal Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 imparements. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational - all All included stroke patients. |
Other: Observational - all
All stroke patients are included.
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Outcome Measures
Primary Outcome Measures
- Medical data Clinical data [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
- Stroke severity [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.
- Functional independence [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
- Walking ability [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.
- Postural control [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.
- Blood samples [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
- FMA-arm test [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.
- SAFE [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.
- MoCA [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.
- Neuroimaging [Baseline, and change from baseline at 3, and 12 months; 2 years]
Changes in MRI scans between baseline and follow-ups.
- D-FIS [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.
- HAD [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.
- SIS [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.
- FAS [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.
- CWT [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.
- TMT [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.
- RBANS [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.
Eligibility Criteria
Criteria
We 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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital | Gothenburg | Sweden | SE-41345 |
Sponsors and Collaborators
- Göteborg University
Investigators
- Principal Investigator: 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: Katarina Jood, MD, PhD, Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- FIND