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A Biomarker for Personalized Care in Post-Stroke Spatial Neglect

A Biomarker for Personalized Care in Post-stroke Spatial Neglect

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05256563
Enrollment
45
Registered
2022-02-25
Start date
2021-09-01
Completion date
2027-07-31
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spatial Neglect, Stroke

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.

Interventions

None listed

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in functional ability for daily life tasks assessed on the FONE-FIM at 3 monthsbaseline to 3 monthsFunctional 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 baselinebaselineCatherine 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 monthsbaseline to 3 monthsFunctional 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 monthsbaseline to 6 monthsFunctional 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 months3 months post-baselineCatherine 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.
SN severity at 6 months6 months post-baselineCatherine 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 monthsbaseline to 6 monthsFunctional 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnna M. Barrett, MD

Atlanta VA Medical and Rehab Center, Decatur, GA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026