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Spatial Neglect and Bias in Near and Far Space

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Kessler Foundation
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00350012
First received: July 6, 2006
Last updated: February 22, 2016
Last verified: February 2016
History of Changes
  Purpose
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
Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Spatial Neglect and Bias in Near and Far Space

Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Improve visual attention [ Time Frame: From 1 or 2 sessions totaling approximately 2 hours to multiple sessions in one year ] [ Designated as safety issue: No ]
Estimated Enrollment: 950
Study Start Date: May 2004
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Persons who have had a stroke
2
Healthy volunteers

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Persons who have had a stroke. Also, healthy volunteers.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350012

Contacts
Contact: Jenny Masmela, BA (973) 324-3564 jmasmela@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Research Center, 1199 Pleasant Valley Way Recruiting
West Orange, New Jersey, United States, 07052
Contact: A M. Barrett, MD    973-324-3569    abarrett@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Anna M. Barrett, MD Stroke Rehabilitation Research, Kessler Foundation Research Center
  More Information

Responsible Party: A. M. Barrett, MD, Director, Stroke Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00350012     History of Changes
Other Study ID Numbers: K02NS047009  5K02NS047099 
Study First Received: July 6, 2006
Last Updated: February 22, 2016
Health Authority: United States: Federal Government

Keywords provided by Kessler Foundation:
stroke
visual
spatial neglect

ClinicalTrials.gov processed this record on September 30, 2016