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Status unknownNCT00990353Updated Feb 17, 2021

A Model to Identify Specific Predictors of Spatial Neglect Recovery

An observational study in Spatial Neglect, Hemispatial Neglect and Hemineglect, sponsored by Kessler Foundation. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Kessler Foundation · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
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Study summary

This study examines methods to better predict improvement of a hidden disability of functional vision, spatial neglect, following stroke. Spatial neglect is a tendency to make visual judgment and movement errors mislocating the body and objects in space. The investigators are using specialized statistical methods to compute the proportion of improvement accounted for by personal characteristics of each stroke survivor, the proportion of improvement accounted for by the unique visual-spatial errors made by each subject, and the proportion of improvement accounted for by each treatment administered. The investigators will also examine whether brain imaging predicts how rapidly improvement occurs. Lastly, the study tests whether improvements that are meaningful to the survivor can be measured in a way that still allows detection of small and scientifically eloquent performance changes.

Read the detailed description

DESCRIPTION: Spatial neglect, pathologically asymmetric spatial behavior resulting from a brain injury (Heilman, 1979) and causing functional disability (Barrett and Burkholder, 2006) may occur in 20-50% of strokes, up to 350,000 Americans annually (Ringman et al., 2004; American Stroke Assoc., 2007). Difficulty eating, dressing, and navigating in complex environments occurs acutely in this disorder, but even if symptoms improve in chronic recovery, people with spatial neglect are more likely to lose functional independence (Katz et al., 1999). Current standard clinical approaches are not theory driven, and widely-employed therapies may be only marginally effective. In this proposal, we suggest two means by which scientific acute spatial neglect treatment can be implemented. In available studies, subject heterogeneity may have obscured treatment effects. Across methods, studies used single subject, case series, and group analytic designs, but did not attempt to reconcile the distinct advantages offered by individual versus group analytic approaches. Different treatments might affect different spatial cognitive recovery functions, but simple, global outcome measures may not reflect these changes. Modeling both subject-specific and group effects is also an extremely useful method of examining targeted treatment effects. We will collect spatial neglect treatment response data over four years, for two promising and feasible spatial neglect treatments: prism adaptation training and dopaminergic medication. With mechanism-specific outcome assessment and hierarchical linear modeling, we will examine whether treatments result in predictable response. We will also examine whether controlling for subject-specific predictors models group recovery trajectory. Lastly, we will examine current standard global outcome measures instruments which have not been fully psychometrically developed, and attempt to predict subject- and group-specific recovery profiles for these variables. We hope this research will improve our ability to design cognitive rehabilitation treatment studies. It may also, however, improve our ability to translate cognitive neuroscience models of action, spatial knowledge, and attention, to treatments to optimize adaptive movement in complex environments. PUBLIC HEALTH RELEVANCE: This study investigates novel methods of outcome analysis for comparing two treatments for hidden disabilities in functional vision after stroke. We hope this research will improve our ability to design cognitive rehabilitation treatment studies. It may also, however, improve our ability to bring basic brain science to the bedside, to optimize stroke survivors' adaptive movement and balanced visual-spatial function in complex environments.

Although subjects are assigned to treatments in this study, we classified the study as observational because there are no quasi-experimental options fitting its hierarchical design under the interventional study description. At no point do we examine the independent effect of treatments; rather, we assign subjects to treatments in order to learn if treatment exerts an additional effect IN COMBINATION WITH 1) individual differences and 2) performance characterization of spatial bias type immediately after stroke. We are lastly making separate examination of the predictive effect of brain lesion location in combination with variables 1) and 2). NO traditional efficacy comparisons between the two treatments to which subjects are assigned, are made. Neither treatment is considered "control" or "placebo," and there is no attempt to match severity or other relevant variables between the two treatment assignments.

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Conditions studied

  • Spatial Neglect
  • Hemispatial Neglect
  • Hemineglect
  • Unilateral Neglect
  • Visual Spatial Neglect
  • Sensory Neglect

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Keywords

  • Spatial neglect
  • hemineglect
  • stroke
  • cognition
  • prism adaptation
  • Hierarchical linear modeling
  • growth curve modeling
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In context

Perceptual Disorders

92 studies on the registry are indexed under Perceptual Disorders; 23 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 19 observational studies indexed under Perceptual Disorders.

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Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stroke survivors with right brain stroke and evidence of a hidden disability of functional vision (spatial neglect)

Inclusion criteria

  • Stroke survivors with right brain stroke and evidence of a hidden disability of functional vision (spatial neglect)
  • Can give consent

Exclusion criteria

Exclusion Criteria:

  • Other neurological conditions
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (estimated)

Groups and cohorts

  • Prism adaptation therapy

    Patients receive prism adaptation therapy by protocol (Frassinetti et al., 2002)

  • Bromocriptine pharmacotherapy

    Patients receive bromocriptine pharmacotherapy by protocol (Barrett et al., 1999)

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What researchers measure

Primary outcomes

  1. Comparing two treatments for hidden disabilities in functional vision after stroke.

    Time frame: 6 months

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Study locations

3 sites
  • Kessler Institute of Rehabilitation
    Chester, New Jersey 07930, United States
  • Kessler Institute of Rehabilitation
    Saddle Brook, New Jersey 07663, United States
  • Kessler Foundation Research Center
    West Orange, New Jersey 07052, United States
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References and documents

Publications

  • Boukrina O, Chen P, Budinoska T, Barrett AM. Exploratory examination of lexical and neuroanatomic correlates of neglect dyslexia. Neuropsychology. 2020 May;34(4):404-419. doi: 10.1037/neu0000619. Epub 2020 Jan 30. PubMed 31999167 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00990353
Lead sponsor
Kessler Foundation
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
A. M. Barrett, MD (Director, Stroke Research, Kessler Foundation) — Principal investigator
First posted
Oct 6, 2009
Start date
Jan 2009
Primary completion
Oct 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Feb 17, 2021

Study contacts

A M Barrett, MD
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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