A Biomarker for Personalized Care in Post-Stroke Spatial Neglect

Active, not recruiting

• Conditions: Stroke; Spatial Neglect

• Registration Number: NCT05256563
• Lead Sponsor: VA Office of Research and Development

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.

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 Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Atlanta VA Medical and Rehab Center, Decatur, GA; 🇺🇸 Decatur, Georgia, United States