A Biomarker for Personalized Care in Post-Stroke Spatial Neglect

Stroke Clinical Trial

Official title:

A Biomarker for Personalized Care in Post-stroke Spatial Neglect

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05256563
• Other study ID #: N3760-P
• Status: Active, not recruiting
• Start date: September 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stroke survivors >18 years

• 1-8 months post-stroke

• Can undergo testing and give informed consent

Exclusion Criteria:

• Other serious

• Chronic neurological disorders

• Evidence of other serious strokes

• Inability to undergo testing or give informed consent

Related Conditions & MeSH terms

• Perceptual Disorders
• Spatial Neglect
• Stroke

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of stroke survivors that have evidence of Aiming SN	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.	baseline
Primary	Change in functional ability for daily life tasks assessed on the FONE-FIM at 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.	baseline to 3 months
Primary	SN severity at 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.	baseline
Primary	Change in functional ability assessed by the Barthel Index at 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.	baseline to 3 months
Primary	Change in functional ability for daily life tasks assessed on the FONE-FIM at 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.	baseline to 6 months
Primary	SN severity at 3 months	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.	3 months post-baseline
Primary	SN severity at 6 months	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.	6 months post-baseline
Primary	Change in functional ability assessed by the Barthel Index at 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.	baseline to 6 months