FIND Stroke Recovery - A Longitudinal Study

NCT05708807 | Recruiting

• 1 other identifier: FIND
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (17)

• 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

Study Arms (1)

Observational - all

All included stroke patients.

Other: Observational - all

Interventions

Observational - all OTHER

All stroke patients are included.

Observational - all

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• first-ever acute ischemic stroke; or intracerebral hemorrhage.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital

Gothenburg, SE-41345, Sweden

RECRUITING

Related Publications (3)

• 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 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.

  PMID: 25276489 BACKGROUND

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke; Ischemic Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 1, 2023
• Study Start: February 1, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)