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A Model to Identify Specific Predictors of Spatial Neglect Recovery

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ClinicalTrials.gov Identifier: NCT00990353
Recruitment Status : Unknown
Verified February 2021 by A. M. Barrett, MD, Kessler Foundation.
Recruitment status was:  Active, not recruiting
First Posted : October 6, 2009
Last Update Posted : February 17, 2021
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation

Brief 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.

Condition or disease
Spatial Neglect Hemispatial Neglect Hemineglect Unilateral Neglect Visual Spatial Neglect Sensory Neglect

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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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparing Prism Adaptation Therapy and Bromocriptine Medication for Spatial Neglect: Theoretical and Practical Outcomes
Study Start Date : January 2009
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Group/Cohort
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)



Primary Outcome Measures :
  1. Comparing two treatments for hidden disabilities in functional vision after stroke. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Other neurological conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990353


Locations
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United States, New Jersey
Kessler Institute of Rehabilitation
Chester, New Jersey, United States, 07930
Kessler Institute of Rehabilitation
Saddle Brook, New Jersey, United States, 07663
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: A M Barrett, MD Kessler Foundation
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A. M. Barrett, MD, Director, Stroke Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00990353    
Other Study ID Numbers: D-624-08
1R01NS055808 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Keywords provided by A. M. Barrett, MD, Kessler Foundation:
Spatial neglect
hemineglect
stroke
cognition
prism adaptation
Hierarchical linear modeling
growth curve modeling
Additional relevant MeSH terms:
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Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases