StrokeFINDNCT05708807
FIND Stroke Recovery - A Longitudinal Study
An observational study of Stroke and Stroke Hemorrhagic, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Hemorrhagic, Stroke, Ischemic
- What is being tested?
- Observational - all
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2018to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital
Gothenburg, SE-41345
Christina Jern, MD, PhD, 031-3435720, david.aberg@gu.se
About this study
Official title: FIND Stroke Recovery: A Longitudinal Frequent Evaluation Long-term Follow-up Study
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.
Read the 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.
- Conditions
- Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Risk Factor, Cardiovascular, Cognitive Impairment
- Being tested
- Observational - all
- Keywords
- recovery, rehabilitation, stroke severity, plasticity, modified Rankin Scale, National Institutes of Health Stroke Scale, Fugl-Meyer assessment, blood sampling, stroke subtype
- Medical subject headings
- Stroke, Hemorrhagic Stroke, Ischemic Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational - allOther
All stroke patients are included.
| Study group | Role | What they receive |
|---|---|---|
| Observational - all | All included stroke patients. Receives: Other: Observational - all |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical data Clinical data
Stroke subtype, medical history, life style questions between baseline and follow-ups
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Feb 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Jern, MD, PhD, Principal investigator, Inst. of Biomedicine, the Sahlgrenska Academy, Univ. of GothenburgTurgut Tatlisumak, MD, PhD, Principal investigator, Dept. of Neurology, Sahlgrenska Univ. Hosp., GothenburgKatarina Jood, MD, PhD, Principal investigator, Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708807
- Sponsor's protocol ID
- FIND
- Acronym
- FIND
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data may be shared by qualified academic research collaborators as long as data transfer is in agreement with EU legislation on the general data protection regulation and decisions by the Ethical Review Board of Sweden and the University of Gothenburg, which should be regulated in a data transfer agreement.
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.
PubMed 16713245Doll 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.
PubMed 25276489Brannmark 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.
PubMed 37164469
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIND Stroke Recovery: A Longitudinal Frequent Evaluation Long-term Follow-up Study
- ClinicalTrials.gov ID
- NCT05708807
- Acronym / sponsor ID
- FIND / FIND
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational - all | – | Other: Observational - allAll included stroke patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational - allAll stroke patients are included. | Other | Observational - all |
Primary outcome
Medical data Clinical data
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, and change from baseline at 3, and 12 months; 2 years
Changes in MRI scans between baseline and follow-ups.
D-FIS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 16713245Wieloch 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.
- Background: PubMed 25276489Doll 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.
- Derived from this study: PubMed 37164469Brannmark 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.
- Individual participant dataSharing planned: No. Anonymized data may be shared by qualified academic research collaborators as long as data transfer is in agreement with EU legislation on the general data protection regulation and decisions by the Ethical Review Board of Sweden and the University of Gothenburg, which should be regulated in a data transfer agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Jern, MD, PhD principal investigator
Inst. of Biomedicine, the Sahlgrenska Academy, Univ. of Gothenburg
Turgut Tatlisumak, MD, PhD principal investigator
Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg
Katarina Jood, MD, PhD principal investigator
Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke Hemorrhagic, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Jern, MD, PhD (+46-31-3435720, christina.jern@neuro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical data Clinical data (time frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.