Cognition And Neocortical Volume After Stroke

NCT02205424 | Completed DMC

• 1 other identifier: APP-1020526
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 3

Brief Summary

Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer's disease. Yet little is known about whether brain volume loss - a hallmark of dementia - occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). The hypotheses are that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

Conditions

Ischaemic Stroke; Alzheimer's Disease; Vascular Dementia

Keywords

Ischaemic stroke; Alzheimer's disease; Brain volume; Cortical thickness; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Difference in total brain volume between 3 month and 3 year time-points

  We will examine changes in brain volume between the 3 month and 3 year time-points in ischemic stroke patients and healthy age-matched control participants

  Between 3 months and 3 years post-stroke

Secondary Outcomes (3)

• Comparison of total brain volume (TBV) change between 3 month and 3 year time-points in those who were cognitively normal (CN) versus cognitively impaired (CI) determined at the 3 months post-stroke time point.

  Between 3 months and 3 years post-stroke

• Difference in hippocampal volume between 3 month and 3 year time-points in stroke and control participants.

  Between 3 months and 3 years post-stroke

• Comparison of hippocampal volume change between 3 month and 3 year time-points in those who were cognitively normal versus cognitively impaired at 3 months post-stroke.

  Between 3 months and 3 years post-stroke

Study Arms (2)

Ischaemic stroke patients

Patients who have suffered an ischaemic stroke, as determined clinically and verified with imaging (CT brain; MRI).

Healthy control participants

People who have never suffered a stroke, and are matched to the ischaemic stroke patient group according to age, education, and vascular risk factors.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ischaemic stroke patients will have been admitted to the Acute Neurology Units of the Austin Hospital (Heidelberg), Royal Melbourne Hospital (Parkville), and Box Hill Hospital (Box Hill).

You may qualify if:

• Clinical stroke
• Aged greater than 18 years;
• Able to have cognitive testing and MRI scan; and
• Able to give informed consent

You may not qualify if:

• Significant medical comorbidities precluding participation in cognitive testing, or making survival for three years unlikely;
• Pre-existing dementia
• Pregnancy, as a precaution to prevent exposing them to multiple MRI scans in a 12-month period
• People in existing dependent or unequal relationships with any member of the research team, to protect against coercion

Sponsors & Collaborators

• The Florey Institute of Neuroscience and Mental Health: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (3)

Eastern Health

Box Hill, Victoria, 3128, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Melbourne Health

Parkville, Victoria, 3050, Australia

Location

Related Publications (4)

• Egorova-Brumley N, Dhollander T, Khan W, Khlif MS, Ebaid D, Brodtmann A. Changes in White Matter Microstructure Over 3 Years in People With and Without Stroke. Neurology. 2023 Apr 18;100(16):e1664-e1672. doi: 10.1212/WNL.0000000000207065. Epub 2023 Feb 15.

  PMID: 36792378 DERIVED

• Hung SH, Khlif MS, Kramer S, Werden E, Bird LJ, Campbell BCV, Brodtmann A. Poststroke White Matter Hyperintensities and Physical Activity: A CANVAS Study Exploratory Analysis. Med Sci Sports Exerc. 2022 Sep 1;54(9):1401-1409. doi: 10.1249/MSS.0000000000002946. Epub 2022 Apr 25.

  PMID: 35482768 DERIVED

• Brodtmann A, Werden E, Khlif MS, Bird LJ, Egorova N, Veldsman M, Pardoe H, Jackson G, Bradshaw J, Darby D, Cumming T, Churilov L, Donnan G. Neurodegeneration Over 3 Years Following Ischaemic Stroke: Findings From the Cognition and Neocortical Volume After Stroke Study. Front Neurol. 2021 Oct 22;12:754204. doi: 10.3389/fneur.2021.754204. eCollection 2021.

  PMID: 34744989 DERIVED

• Brodtmann A, Khlif MS, Egorova N, Veldsman M, Bird LJ, Werden E. Dynamic Regional Brain Atrophy Rates in the First Year After Ischemic Stroke. Stroke. 2020 Sep;51(9):e183-e192. doi: 10.1161/STROKEAHA.120.030256. Epub 2020 Aug 10.

  PMID: 32772680 DERIVED

Related Links

• Primary and secondary hypotheses reporting

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood for APOE estimation.

MeSH Terms

Conditions

Ischemic Stroke; Alzheimer Disease; Dementia, Vascular

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Amy G Brodtmann, MBBS PhD

  The Florey Institute of Neuroscience and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Amy Brodtmann

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: July 31, 2014
• Study Start: May 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)