A Biomarker for Personalized Care in Post-Stroke Spatial Neglect
Study Details
Study Description
Brief Summary
More than 30,000 Veterans are hospitalized for stroke each year, and in the critical first months of recovery, at least half are disabled by abnormal 3-D spatial function (spatial neglect). Their self-care, mobility, and ability to return home are severely limited.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Spatial Neglect (SN)is an underdiagnosed stroke-related condition--and a specific core set of symptoms--Aiming Spatial Neglect-- may have a major adverse effect on outcome. These same symptoms may predict excellent response to spatial neglect therapy. The investigators seek to develop a biological parameter for treatment assignment. In this two-year study, the investigators will enroll 45 people with right brain stroke who are at high risk of SN. The investigators will examine clinical brain images, behavioral assessment and research brain images at baseline and recovery at 3 and 6 months after study entry.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Right brain stroke survivors People with right brain stroke who are recruited to the study. |
Outcome Measures
Primary Outcome Measures
- Change in functional ability for daily life tasks assessed on the FONE-FIM at 3 months [baseline to 3 months]
Functional performance of daily life tasks will be assessed with the FONE-FIM questionnaire. This variable assesses improvement between baseline and 3 months. The FONE-FIM has has a minimum score of 18 and a maximum score of 126, being 126 the maximum level of independence in daily life activities. Therefore, change can be 0-108 points.
- SN severity at baseline [baseline]
Catherine Bergego Scale--an examiner-assessed measure of functional performance specific to SN. The score goes from 0 to 30 determining mild (0-10), moderate (11-20) or severe (21-30) spatial neglect.
- Change in functional ability assessed by the Barthel Index at 3 months [baseline to 3 months]
Functional performance of daily life tasks will be assessed with the Barthel Index questionnaire. This is has a minimum score of 0 and a maximum score of 100, with100 the maximum amount of help a person might need to perform daily life activities. Therefore, change at 3 months can be 0-100 points.
- Change in functional ability for daily life tasks assessed on the FONE-FIM at 6 months [baseline to 6 months]
Functional performance of daily life tasks will be assessed with the FONE-FIM questionnaire. This variable assesses improvement between baseline and 6 months. The FONE-FIM has has a minimum score of 18 and a maximum score of 126, being 126 the maximum level of independence in daily life activities. Therefore, change can be 0-108 points.
- SN severity at 3 months [3 months post-baseline]
Catherine Bergego Scale--an examiner-assessed measure of functional performance specific to SN. The score goes from 0 to 30 determining mild (0-10), moderate (11-20) or severe (21-30) spatial neglect.
- SN severity at 6 months [6 months post-baseline]
Catherine Bergego Scale--an examiner-assessed measure of functional performance specific to SN. The score goes from 0 to 30 determining mild (0-10), moderate (11-20) or severe (21-30) spatial neglect.
- Change in functional ability assessed by the Barthel Index at 6 months [baseline to 6 months]
Functional performance of daily life tasks will be assessed with the Barthel Index questionnaire. This is has a minimum score of 0 and a maximum score of 100, with100 the maximum amount of help a person might need to perform daily life activities. Therefore, change at 6 months can be 0-100 points.
Other Outcome Measures
- Number of stroke survivors that have evidence of Aiming SN [baseline]
The investigators will examine whether or not stroke survivors have evidence of Aiming SN on validated measures such as the Computerized Line Bisection where the person must bisect lines using the computer mouse. This tests determines if the person has an aiming or where bias.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stroke survivors >18 years
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1-8 months post-stroke
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Can undergo testing and give informed consent
Exclusion Criteria:
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Other serious
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Chronic neurological disorders
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Evidence of other serious strokes
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Inability to undergo testing or give informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | United States | 30033 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Anna M. Barrett, MD, Atlanta VA Medical and Rehab Center, Decatur, GA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N3760-P