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NCT Number: NCT05256563

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Spatial Neglect Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in functional ability for daily life tasks assessed on the FONE-FIM at 3 months

    Time frame: 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.

  2. SN severity at baseline

    Time frame: 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.

  3. Change in functional ability assessed by the Barthel Index at 3 months

    Time frame: 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.

  4. Change in functional ability for daily life tasks assessed on the FONE-FIM at 6 months

    Time frame: 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.

  5. SN severity at 3 months

    Time frame: 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.

  6. SN severity at 6 months

    Time frame: 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.

  7. Change in functional ability assessed by the Barthel Index at 6 months

    Time frame: 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 outcomes

  1. Number of stroke survivors that have evidence of Aiming SN

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2022
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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