Spatial Neglect and Bias in Near and Far Space

Sponsor
Kessler Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00350012
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
950
1
209
4.5

Study Details

Study Description

Brief Summary

The purpose of this research study is to learn how people distribute their visual attention when looking at objects nearby versus far away, and why vision may become distracted at near versus far distances.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Visual distraction is a problem that more often occurs people who have suffered strokes than in the general population. Problems of visual attention generally appear immediately following a stroke, and may impair driving and other functions. While it is thought that there is a natural course of improvement over time, little is known about how this improvement occurs. Some studies suggest that recovery is only partial, meaning certain aspects of visual attention may improve while other aspects remain but escape notice.

    The purpose of this study is to examine the effect of stroke on a person's visual attention when looking at objects nearby versus far away, and to learn why a person's visual attention may become more distracted at near versus far distances. The purpose of this study is also to understand how modeled interventions, such as eye patching or prism goggles, affect impairment measures of visual attention.

    After an initial screening (including attention, thinking, memory, and visual judgment tests), participants will be given a neurological examination. Participants may be asked to perform visual tasks while wearing an eye patch or prism goggles. Next, they will be asked to perform a line bisection task by looking at lines on a video screen either at close or far distances and, using a laser pointer, marking the center of the lines as they appear on-screen. Participants may be asked to perform other, similar visual tasks as well.

    Duration of the study for participants varies, ranging from 1 or 2 sessions totaling approximately 2 hours to multiple sessions spanning a year.

    Research from this study may help researchers better understand problems associated with stroke and may lead to therapies designed to promote improved visual attention.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    950 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Spatial Neglect and Bias in Near and Far Space
    Study Start Date :
    May 1, 2004
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Oct 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Persons who have had a stroke and either have, or do not have, a pathological asymmetry of perception, attention and action causing functional disability (spatial neglect; Barrett and Burkholder, 2006).

    2

    Healthy age- and education-matched volunteers

    Outcome Measures

    Primary Outcome Measures

    1. Kessler Foundation Neglect Assessment Process [From 1 or 2 sessions totaling approximately 2 hours to multiple sessions in one year]

      a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)

    Secondary Outcome Measures

    1. Behavior Inattention Test Behavior Inattention Test [2 weeks]

      Conventional subtest, a set of paper and pencil test for spatial neglect

    2. Barthel Index [2 weeks]

      A functional independence assessment of daily tasks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • The subject has a history of stroke.

    • The subject is 18 to 100 years old.

    • The subject is able to give Informed consent.

    • The subject is post-Stroke with left-hemisphere injury and has no spatial neglect (no attentional imbalance).

    • The subject is post-stroke with right hemisphere damage and has spatial neglect (attentional imbalance).

    • Healthy subject with no brain injury.

    • The subject is post stroke and has hemianopia (a "visual field cut").

    • The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits.

    Exclusion Criteria:
    • Subjects with brain tumors, head injury with loss of consciousness, visual disorders other than corrected near or far-sightedness, history of learning disabilities, dementia or Alzheimer's Disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kessler Foundation, 1199 Pleasant Valley Way West Orange New Jersey United States 07052

    Sponsors and Collaborators

    • Kessler Foundation
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: A. M. Barrett, MD, Stroke Rehabilitation Research, Kessler Foundation Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    A. M. Barrett, MD, Director, Stroke Research, Kessler Foundation
    ClinicalTrials.gov Identifier:
    NCT00350012
    Other Study ID Numbers:
    • K02NS047009
    • 5K02NS047099
    First Posted:
    Jul 10, 2006
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by A. M. Barrett, MD, Director, Stroke Research, Kessler Foundation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2021