FIND Stroke Recovery - A Longitudinal Study

Stroke Clinical Trial

— FIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708807
• Other study ID #: FIND
• Status: Recruiting
• Start date: February 1, 2018
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2023
• Source: Göteborg University
• Contact: Christina Jern, MD, PhD
• Phone: +46-31-3435720
• Email: christina.jern[@]neuro.gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Hemorrhagic Stroke
• Ischemic Stroke
• Risk Factor, Cardiovascular
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

Other:
• Observational - all
All stroke patients are included.

Locations

Country	Name	City	State
Sweden	Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Neuroimaging	Changes in MRI scans between baseline and follow-ups.	Baseline, and change from baseline at 3, and 12 months; 2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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