NCT05653141

Brief Summary

Present study aims to track the post-stroke cognitive trajectories and to investigate its inter-individual variability.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Dec 2020Oct 2029

Study Start

First participant enrolled

December 17, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

5.9 years

First QC Date

November 23, 2022

Last Update Submit

April 29, 2026

Conditions

First-ever Ischemic StrokeCognitive Performance

Keywords

Ischemic strokeCognitive reserve

Outcome Measures

Primary Outcomes (2)

  • Number of participants with delayed cognitive deterioration (DCD)

    The investigators will assess number of participants with deterioration of the cognitive performance in ≥2 cognitive domains on ≥ 1 Standard Deviation (1 SD).

    at 3 months, at 12 months and at 36 months post-stroke

  • Number of participants with delayed functional deterioration

    The investigators will assess number of participants with deterioration of functional disability will be defined as decrease in disability level to one point assessed via modified Rankin Scale (mRS, 0-6, whereas 0=no functional disability).

    at 3 months, at 12 months and at 36 months post-stroke

Secondary Outcomes (1)

  • Number of participants with post-stroke cognitive impairment

    10 days post-stroke, 3 months, 12 months and at 36 months post-stroke

Study Arms (1)

Stroke patients

Adults with first-ever anterior circulation stroke

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study recuits patients hospitalized at the Department of Neurology of the University Hospital of Bern (Inselspital)

You may qualify if:

  • Age ≥18 years old
  • First-ever anterior circulation ischemic stroke confirmed by routine MRI
  • Time of enrollment: ≤ 10 days from stroke onset.

You may not qualify if:

  • Previous stroke anamnestic or based on clinical imaging
  • Additional stroke in posterior circulation
  • Conditions that preclude the cognitive testing (e.g. delirium, intubation, reduced vigilance
  • Neurological or psychiatric conditions that preclude the data interpretation (e.g. pre-stroke dementia, schizophrenia, brain tumor, regular intake of benzodiazepine, depression)
  • MRI contraindication
  • Native language other than German, French or Italian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Inselspital, University Hospital Bern, University of Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (2)

  • Umarova RM. Adapting the concepts of brain and cognitive reserve to post-stroke cognitive deficits: Implications for understanding neglect. Cortex. 2017 Dec;97:327-338. doi: 10.1016/j.cortex.2016.12.006. Epub 2016 Dec 16.

    PMID: 28049565BACKGROUND

  • Gallucci L, Sperber C, Monsch AU, Kloppel S, Arnold M, Umarova RM. Improving diagnostic accuracy of the Montreal Cognitive Assessment to identify post-stroke cognitive impairment. Sci Rep. 2024 Aug 29;14(1):20125. doi: 10.1038/s41598-024-71184-x.

    PMID: 39209968DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Roza M. Umarova, PD Dr.

    Department of Neurology, Inselspital, University Hospital Bern, University of Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roza M. Umarova, PD Dr.

CONTACT

+41316327000roza.umarova@insel.ch

Laura Gallucci, MSc

CONTACT

+41316641506laura.gallucci@extern.insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr., Principal Investigator, Head of out-patient clinic of cognitive neurology

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 16, 2022

Study Start

December 17, 2020

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

CH(1)