Clinical trial NCT05708807: FIND Stroke Recovery - A Longitudinal Study
Official title: FIND Stroke Recovery: A Longitudinal Frequent Evaluation Long-term Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Stroke Hemorrhagic
Stroke, Ischemic
Risk Factor, Cardiovascular
Cognitive Impairment
Keywords: recovery
rehabilitation
stroke severity
plasticity
modified Rankin Scale
National Institutes of Health Stroke Scale
Fugl-Meyer assessment
blood sampling
stroke subtype
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medical data Clinical data
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
measure: Stroke severity
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
measure: Functional independence
timeFrame: Pre-stroke estimation, baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
measure: Walking ability
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
measure: Postural control
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
measure: Blood samples
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: FMA-arm test
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: SAFE
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: MoCA
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: Neuroimaging
timeFrame: Baseline, and change from baseline at 3, and 12 months; 2 years
measure: D-FIS
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: HAD
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: SIS
timeFrame: Baseline, and change from baseline and 3, 6 and 12 months; 2 and 5 years
measure: FAS
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: CWT
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: TMT
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
measure: RBANS
timeFrame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital
Study officials:
affiliation: Inst. of Biomedicine, the Sahlgrenska Academy, Univ. of Gothenburg
name: Christina Jern, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg
name: Turgut Tatlisumak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg
name: Katarina Jood, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.