NCT00350012

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

17.4 years

First QC Date

July 6, 2006

Last Update Submit

February 16, 2021

Conditions

Keywords

strokevisualspatial neglect

Outcome Measures

Primary Outcomes (1)

  • Kessler Foundation Neglect Assessment Process

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

    From 1 or 2 sessions totaling approximately 2 hours to multiple sessions in one year

Secondary Outcomes (2)

  • Behavior Inattention Test Behavior Inattention Test

    2 weeks

  • Barthel Index

    2 weeks

Study Arms (2)

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

Eligibility Criteria

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

Persons who have had a stroke. Also, healthy volunteers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation, 1199 Pleasant Valley Way

West Orange, New Jersey, 07052, United States

Location

Related Publications (2)

  • Boukrina O, Chen P, Budinoska T, Barrett AM. Exploratory examination of lexical and neuroanatomic correlates of neglect dyslexia. Neuropsychology. 2020 May;34(4):404-419. doi: 10.1037/neu0000619. Epub 2020 Jan 30.

  • Caulfield MD, Chen P, Barry MM, Barrett AM. Which perseverative behaviors are symptoms of spatial neglect? Brain Cogn. 2017 Apr;113:93-101. doi: 10.1016/j.bandc.2016.11.002. Epub 2017 Feb 3.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • A. M. Barrett, MD

    Stroke Rehabilitation Research, Kessler Foundation Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Stroke Research

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

May 1, 2004

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations