A Biomarker for Personalized Care in Post-Stroke Spatial Neglect

A Biomarker for Personalized Care in Post-stroke Spatial Neglect

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Spatial Neglect

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033-4004
      • Atlanta VA Medical and Rehab Center, Decatur, GA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

See Inclusion and Exclusion Criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Right brain stroke survivors; People with right brain stroke who are recruited to the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Anna M. Barrett, MD, Atlanta VA Medical and Rehab Center, Decatur, GA

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: N3760-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No