A Biomarker for Personalized Care in Post-Stroke Spatial Neglect

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT05256563
Collaborator
(none)
45
1
18.9
2.4

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

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    45 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Biomarker for Personalized Care in Post-stroke Spatial Neglect
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Mar 31, 2023
    Anticipated Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Right brain stroke survivors

    People with right brain stroke who are recruited to the study.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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

    1. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05256563
    Other Study ID Numbers:
    • N3760-P
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 25, 2022