Spatial Neglect and Delirium After Stroke
Right Brain Stroke and the Neural Substrate of Delirium
1 other identifier
observational
45
1 country
2
Brief Summary
The goal of this study is to understand what brain mechanisms become disrupted when stroke survivors experience delirium. Delirium is an acute reduction in attention and cognition, associated with poor recovery, longer hospitalization and even death. One major factor increasing the risk of delirium after stroke may be spatial neglect occurring after stroke on the right side of the brain. Spatial neglect affects awareness, orientation, and movement. The study will test the hypothesis that the right-dominant brain networks for arousal and attention are affected in both of these disorders. It is expected that the activity and structural integrity of these brain networks will correlate with behavioral signs and severity of delirium and spatial neglect. To test this hypothesis, the study will measure spatial neglect and delirium symptoms in 45 acute (NYC Health + Hospitals/Bellevue ) and 30 subacute (Kessler Institute for Rehabilitation) stroke survivors and evaluate brain scans for these participants. This study may contribute to knowledge about brain bio-markers of delirium, which will greatly aid in delirium detection in stroke and other disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2017
CompletedFirst Submitted
Initial submission to the registry
November 17, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedApril 30, 2021
April 1, 2021
3.5 years
November 17, 2017
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
fMRI
functional connectivity
within 1 week of study enrollment
Secondary Outcomes (3)
Confusion Assessment Method - Severity
within 1 week of enrollment
Diffusion MRI
within 1 week of study enrollment
structural MRI
within 1 month of enrollment
Study Arms (2)
Acute Ischemic Stroke Sample
45 acute patients with first ever ischemic stroke on the right side of the brain will be recruited at NYC Health + Hospitals/Bellevue . They will undergo testing with the Confusion Assessment Method (CAM), Behavioral Inattention Test (BIT), Montreal Cognitive Assessment (MOCA) and Geriatric Depression Scale (GDS)
Subacute Ischemic Stroke Sample
30 patients with first ever ischemic stroke on the right side of the brain who are within 3 months of their stroke will be recruited at Kessler Institute for Rehabilitation. They will undergo testing with the Confusion Assessment Method (CAM), Behavioral Inattention Test (BIT), Florida Mental Status Examination (FMSE); Kessler Foundation Neglect Assessment Process (KF-NAP); and Geriatric Depression Scale (GDS). These participants will also complete a research Magnetic Resonance Imaging (MRI) scan.
Interventions
This test is used for delirium assessment. The CAM consists of a series of questions, measuring attention (digits forward and backwards, days of the week and months of the year backwards), orientation (person, place, time), memory (immediate and delayed recall of 3 concrete nouns); and probing for any sleep, perceptual, or thinking disturbances. It was designed to incorporate DSM-III criteria for delirium.
This test is used for neglect assessment. The BIT consists of 6 tasks: figure and shape copying; line, star, and letter cancellation, and representational drawing. Such tasks were shown to be appropriate in patients within 48 hours of stroke onset. Scoring of each test will include proportion of error responses on each test or deviation from midpoint on line bisection. Figure and shape copying and representational drawing will be scored based on each item completed.
Structural, functional and diffusion weighted scans will be obtained or acquired, depending on the cohort. Subacute sample participants will undergo a research MRI scan, whereas acute sample participants will allow the release of their clinical MRI scans.
This test is used for mental status assessment, and it will be conducted in our subacute sample only. The FMSE tests memory, attention, language, visuospatial processing, and executive function. It will help to establish patients' mental status profile, including any deficits.
MoCA is a brief cognitive screening tool for individuals with mild cognitive impairment and will be used in the acute sample.
Because depression has been previously associated with delirium, patients will be evaluated for depression with the GDS. The GDS is a self-report measure consisting of 30 yes/no questions to measure depression in the elderly. It will be used as a covariate in data analysis.
This is a 10-category scale for spatial neglect based on observation of activities of daily living (e.g., eating, dressing, grooming, gaze orientation). Thee test is based on the Catherine Bergego Scale (CBS) and administered via the standardized KF-Neglect Assessment Process developed within our program.
Eligibility Criteria
This is a prospective observational study using a consecutive patient sample. The study will be carried out at 2 sites: NYC Health + Hospitals/Bellevue and Kessler Institute for Rehabilitation. 1st ever ischemic stroke patients will be approached for interest in participation. Patients of both sexes whose stroke event is on the right side of the brain and who qualify for the study based on the inclusion and exclusion criteria will be recruited.
You may qualify if:
- \- Able to give informed consent prior to beginning of testing; have 1st ever ischemic stroke on the right side of the brain; speaks English; \>18 years of age
You may not qualify if:
- all of the following will be excluded:
- Participants with another brain disorder expected to produce severe visual-spatial abnormalities (including malignant brain tumor, traumatic brain injury with post-injury neurological problems, or Alzheimer's Disease)
- Women knowing themselves to be pregnant will not be enrolled; pregnancy may itself affect visual-spatial attention. However, women of childbearing potential will not be tested for pregnancy before participating.
- Persons consuming more than 10 alcoholic beverages weekly
- For participants who will undergo an MRI scan the following will be excluded:
- Pacemaker or other implanted electrical device incompatible with the MR environment
- Eye injury to the eye involving metal filings
- Unable to undergo MRI due to doctor recommendation
- Claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kessler Foundationlead
- NYU Langone Healthcollaborator
Study Sites (2)
Kessler Foundation
West Orange, New Jersey, 07052, United States
NYC Health + Hospitals/Bellevue
New York, New York, 10016, United States
Related Publications (2)
Boukrina O, Barrett AM. Disruption of the ascending arousal system and cortical attention networks in post-stroke delirium and spatial neglect. Neurosci Biobehav Rev. 2017 Dec;83:1-10. doi: 10.1016/j.neubiorev.2017.09.024. Epub 2017 Sep 27.
PMID: 28963037RESULTBoukrina O, Kowalczyk M, Koush Y, Kong Y, Barrett AM. Brain Network Dysfunction in Poststroke Delirium and Spatial Neglect: An fMRI Study. Stroke. 2022 Mar;53(3):930-938. doi: 10.1161/STROKEAHA.121.035733. Epub 2021 Oct 8.
PMID: 34619987DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olga Boukrina, Ph.D.
Kessler Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Week
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
November 17, 2017
First Posted
November 21, 2017
Study Start
July 18, 2017
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
April 30, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Anticipated 6/30/2021, de-identified data will be stored indefinitely
- Access Criteria
- Factual data (including raw data and metadata, such as study design, description of tests, and how they were conducted) will be made freely and publicly available via the Open Science Framework. Users will need to register on the website to access data.
Some of the data collected during this project must be publicly shared no later than 1 year from the date of project completion. The purpose of data sharing is to allow other scientists to independently verify study results.