FIND Stroke Recovery - A Longitudinal Study

Official title

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

Overview

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.

Interventions

• Other Observational - all
  All stroke patients are included.

Primary outcome measures

• Medical data Clinical data [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.]
• Stroke severity [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.]
• Functional independence [Time frame: Pre-stroke estimation, baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.]
• Walking ability [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.]
• Postural control [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.]
• Blood samples [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years]
• FMA-arm test [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years]
• SAFE [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years]
• MoCA [Time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years]
• Neuroimaging [Time frame: Baseline, and change from baseline at 3, and 12 months; 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Sweden · 1 center

• Department of Neurology, Department of Neurorehabilitation and Department of Clinical Gene — Gothenburg

Publications

• 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. PMID 16713245
• 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. PMID 25276489
• 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. PMID 37164469

Identifiers

NCT: NCT05708807 · FIND

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗