Spatial Neglect and Bias in Near and Far Space
| Tracking Information | |||||
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| First Received Date ICMJE | July 6, 2006 | ||||
| Last Updated Date | May 11, 2013 | ||||
| Start Date ICMJE | May 2004 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00350012 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Spatial Neglect and Bias in Near and Far Space | ||||
| Official Title ICMJE | Spatial Neglect and Bias in Near and Far Space | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Persons who have had a stroke. Also, healthy volunteers. |
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| Condition ICMJE | Stroke | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 950 | ||||
| Estimated Completion Date | April 2015 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00350012 | ||||
| Other Study ID Numbers ICMJE | K02NS047009, 5K02NS047099 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | A. M. Barrett, MD, Kessler Foundation | ||||
| Study Sponsor ICMJE | Kessler Foundation | ||||
| Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Investigators ICMJE |
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| Information Provided By | Kessler Foundation | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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