Spatial Neglect and Delirium After Stroke

NCT03349411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2021-04-30

No results posted yet for this study

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.

Conditions

  • Stroke
  • Delirium
  • Spatial Neglect

Interventions

DIAGNOSTIC_TEST

Confusion Assessment Method

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.

DIAGNOSTIC_TEST

Behavioral Inattention Test

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.

DIAGNOSTIC_TEST

Magnetic Resonance Imaging

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.

DIAGNOSTIC_TEST

Florida Mental Status Examination

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.

DIAGNOSTIC_TEST

Montreal Cognitive Assessment

MoCA is a brief cognitive screening tool for individuals with mild cognitive impairment and will be used in the acute sample.

DIAGNOSTIC_TEST

Geriatric Depression Scale

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.

DIAGNOSTIC_TEST

Kessler Foundation Neglect Assessment Process

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.

Sponsors & Collaborators

Principal Investigators

  • Olga Boukrina, Ph.D. · Kessler Foundation

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349411 on ClinicalTrials.gov