StrokeNCT00350012
Spatial Neglect and Bias in Near and Far Space
An observational study of Stroke, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 950 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons who have had a stroke. Also, healthy volunteers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Foundation, 1199 Pleasant Valley Way
West Orange, New Jersey, 07052
About this study
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- stroke, visual, spatial neglect
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From 1 or 2 sessions totaling approximately 2 hours to multiple sessions in one year
Secondary outcomes (2)
Behavior Inattention Test Behavior Inattention Test
Conventional subtest, a set of paper and pencil test for spatial neglect
Measured: 2 weeks
Barthel Index
A functional independence assessment of daily tasks
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startMay 2004
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. M. Barrett, MD, Kessler Foundation
- Investigators
- A. M. Barrett, MD, Principal investigator, Stroke Rehabilitation Research, Kessler Foundation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350012
- Sponsor's protocol ID
- K02NS047009
- Other IDs
- 5K02NS047099
- Status last verified
- Feb 2021
- First submitted
- 6 Jul 2006
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31999167Caulfield 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.
PubMed 28167411
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Neglect and Bias in Near and Far Space
- ClinicalTrials.gov ID
- NCT00350012
- Acronym / sponsor ID
- K02NS047009
- Conditions
- Stroke
- Keywords
- stroke, visual, spatial neglect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2004
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons who have had a stroke. Also, healthy volunteers.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kessler Foundation Neglect Assessment Process
Time frame: 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)
2 secondary outcomes
Behavior Inattention Test Behavior Inattention Test
Time frame: 2 weeks
Barthel Index
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 31999167Boukrina 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.
- Derived from this study: PubMed 28167411Caulfield 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. M. Barrett, MD principal investigator
Stroke Rehabilitation Research, Kessler Foundation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler Foundation Neglect Assessment Process (time frame: From 1 or 2 sessions totaling approximately 2 hours to multiple sessions in one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00350012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.